Trabajos pharmaceutical compliance en Commack, New YorkCrear alertas

Job DescriptionDescription: A Packaging Machine Operator is responsible for the general handling of material before, during, and after packaging runs. *Multiple Shifts Available - Day, Night, Weekend - Full & Part Time Opportunities Requirements: Responsibilities: Responsibilities include, but are not limited to: • Bringing raw material to the production line, in-process material to the next process step., • Run the fillers, assemble and disassemble the filler machine., • Put product and components into the hopper., • Prior to packaging process, operator must set up filler parameters, weight, quality, make sure product quality is acceptable (depends on workstation or work order requirements), • Assist the line leader for properly signing and following work order instructions, as well as correctly fill out packaging order., • Maintaining a clean and organized workstation., • Assist Line Leaders with general cleaning and whenever help is required., • Assist Line leader in end of run procedures., • Notify management of any quality or safety concerns., • Training and compliance with general procedures and applicable company policies such as Good Hygiene Practice, current Good Manufacturing Practice (cGMP), and related Standard Operating Procedures (SOP)., • Responsible for compliance with all rules and regulations pertaining to safety policies and leading by example with the proper attitude toward safety and health. Help to ensure that all department operations are performed with the utmost regard for the safety and health for all personnel., • Frequently required to sit, speak and hear., • Vision abilities required include close vision, distance vision, peripheral vision, color vision and the ability to adjust focus., • Other responsibilities as assigned by management Education and Experience: • High School or GED diploma preferred., • Operator Level I: 6 months+ experience in pharmaceutical production environment., • Operator Level II: 2+ years of work experience in pharmaceutical production environment., • Operator Level III: 5+ years of work experience in pharmaceutical production environment. Skills, Knowledge and Abilities: • Ability to comprehend, follow and accurately perform all instructions detailed in batch production record., • Ability to work independently., • Work experience in GMP environment a plus Physical Demands: • Required to use hands to handle or feel objects, tools, computer controls, equipment., • While performing the duties of this job, the employee is regularly required to stoop, kneel, crouch, climb, stand, bend, sit, talk, hear, or walk for prolonged periods. The employee may lift, move and or carry up to 50 lbs., • Specific vision abilities required include close vision, distance vision, peripheral vision, color vision and the ability to adjust focus. Work Environment: • Work environment in production operations facilities include close proximity to heavy machinery and pharmaceutical powders (dust), with loud noises., • Required to be present at designated facilities to provide immediate departmental support daily., • Employee travel/work hours/schedule/location and/or shift are subject to change based on business needs and management discretion., • Regular, ongoing travel throughout geographic areas on a continual basis as normal scope of role. Personal Protective Equipment Required for Position: • PPE / GMP gowning Pay Range*: • Operator I: $17.10 - $20.00 / hour, • Operator II: $17.00 - $19.60 / hour, • Operator III: $17.85 - $20.60 / hour *Ranges indicated account for all shifts. Please indicate your shift preference when applying.

Job DescriptionDescription: Position Summary: A Materials Processing Machine Operator is responsible for operating blending, granulation, and/or compounding equipment in accordance with all applicable regulatory requirements, standard operating procedures (SOPs), and company policies. *Multiple Shifts Available - Day, Night, Overnight, Weekend - Full & Part Time Opportunities Responsibilities: Including but not limited to - • Screening, loading and unloading of raw materials to and from manufacturing equipment such as blenders, screeners, ovens, mills, bowls, and granulators., • Unload the mixed raw materials from the equipment into drums., • Properly label the drums to avoid cross contamination., • Report any abnormalities to the department supervisor., • Accurately complete documentation in the batch record., • Maintain cleanliness of production rooms and equipment to prevent contamination., • Maintain a safe working environment., • Execute standard work practice with 1st time right quality standard., • Maintain a cGMP environment in accordance with Company policies, FDA regulations and any other governing regulatory agency requirements., • Other responsibilities as assigned by management.Requirements: Education and Experience: • High School or GED diploma preferred., • Operator Level I: 6 months+ experience in pharmaceutical blending, granulation and/or compounding, • Operator Level II: 2+ years of work experience in pharmaceutical blending, granulation and/or compounding, • Operator Level III: 5+ years of work experience in pharmaceutical blending, granulation and/or compounding Skills, Knowledge and Abilities: • Ability to comprehend, follow and accurately perform all instructions detailed in batch production record., • Ability to work independently. Physical Demands: • Required to use hands/fingers to operate machinery, etc., • Must be able to lift up to 50 pounds for a distance of 20-30 feet., • Must be able to stand, kneel, climb and bend for extended periods of time., • Specific vision abilities required include close vision, distance, peripheral, color and ability to adjust focus. Work Environment: • Indoor manufacturing environment including enclosed areas with dust and loud noises; close proximity to heavy machinery and pharmaceutical powders., • Potential to move between production operations sites/areas to complete job functions., • Responsible for compliance with all rules and regulations pertaining to safety policies and for leading by example with the proper attitude toward safety and health, helping to ensure that all department operations are performed with the utmost regard for the safety and health for all personnel. Personal Protective Equipment Required for Position: • PPE / GMP gowning Pay Range*: • Operator I: $19.00 - $23.00 / hour, • Operator II: $20.50 - $24.50 / hour, • Operator III: $22.00 - $26.00 / hour *Ranges indicated account for all shifts. Please indicate your shift preference when applying.

Job DescriptionDescription: Position Summary: A Coating Machine Operator is responsible for the regulation and operation of equipment used in the coating process of pharmaceutical products. *Multiple Shifts Available - Day, Night, Overnight, Weekend - Full & Part Time Opportunities Responsibilities: Including but not limited to - • Accurately prepare documentation regarding coating process., • Handle materials such as bulk tablets and coating solutions, as outlined in company procedure., • Set-up coating pans and calibrate spray guns., • Load tablets into the coating pan and unload finished products; ability to operate a drum lift., • Operate powered equipment as required (i.e., Pallet Jack)., • Appropriately document and dispose of rejected tablets and powder waste., • Maintain cleanliness of coating rooms and machines to prevent contamination., • Ensure products are coated to conform to specifications., • Maintain a safe working environment., • Execute standard work practice with 1st time right quality standard., • Maintain a cGMP environment in accordance with Company policies, FDA regulations and any other governing regulatory agency requirements., • Other responsibilities as assigned by management.Requirements: Education and Experience: • High School or GED diploma preferred., • Operator Level I: 6 months+ experience in pharmaceutical compression/encapsulation, • Operator Level II: 2+ years of work experience in pharmaceutical compression/encapsulation, • Operator Level III: 5+ years of work experience in pharmaceutical compression/encapsulation Skills, Knowledge and Abilities: • Ability to comprehend, follow and accurately perform all instructions detailed in batch production record., • Ability to work independently. Physical Demands: • Required to use hands/fingers to operate machinery, etc., • Must be able to lift up to 50 pounds for a distance of 20-30 feet., • Must be able to stand, kneel, climb and bend for extended periods of time., • Specific vision abilities required include close vision, distance, peripheral, color and ability to adjust focus. Work Environment: • Indoor manufacturing environment including enclosed areas with dust and loud noises; close proximity to heavy machinery and pharmaceutical powders., • Potential to move between production operations sites/areas to complete job functions., • Responsible for compliance with all rules and regulations pertaining to safety policies and for leading by example with the proper attitude toward safety and health, helping to ensure that all department operations are performed with the utmost regard for the safety and health for all personnel. Personal Protective Equipment Required for Position: • PPE / GMP gowning Pay Range*: • Operator I: $19.00 - $23.00 / hour, • Operator II: $20.50 - $24.50 / hour, • Operator III: $22.00 - $26.00 / hour *Ranges indicated account for all shifts. Please indicate your shift preference when applying.

Job Description Job Overview We are seeking a dedicated and detail-oriented Staff Pharmacist to join our growing independent pharmacy. The ideal candidate will will be responsible for ensuring the safe and accurate dispensing of medications, providing excellent patient care , and supporting daily pharmacy operations . This role requires strong clinical knowledge customer service skills,and the ability to work efficiently in a fast-paced environment . The Staff Pharmacist will play a vital role in optimizing medication therapy, supporting medical teams, and enhancing patient outcomes across diverse clinical environments such as hospitals, pediatrics, and acute care facilities. Duties • Dispense prescriptions accurately using Micro Merchant software systems while ensuring adherence to HIPAA regulations., • Conduct comprehensive patient assessments to determine appropriate medication therapy and monitor patient responses., • Oversee pharmacy technicians and support staff, • Administer immunizations and provide patient education on medication use, side effects, and health management strategies., • Manage inventory levels of pharmaceuticals, including controlled substances, ensuring proper storage and documentation., • Collaborate with healthcare professionals to develop individualized treatment plans for pain management, medical management, and other therapeutic areas such as pediatrics and physiology., • Assist in training pharmacy technicians and supporting staff to maintain high standards of patient service and operational efficiency., • Able to assist DR'S with prior authorizations, • Document and resolve DUR alerts through prescriber communication and patient counseling, • Valid pharmacist license with current registration in the state of practice., • Experience with inventory management, medication safety protocols, HIPAA compliance, and patient service excellence., • Ability to perform patient assessments effectively while providing compassionate care tailored to individual needs., • Prior experience working with pharmacy technicians or supporting staff is advantageous. This position offers an opportunity to contribute significantly to patient health outcomes through expert pharmaceutical care while working within a collaborative healthcare environment committed to excellence in service delivery.

Job DescriptionDescription: Are you passionate about science and precision? Join our Quality Control team as a Laboratory Technician and gain hands-on experience performing chemical and microbial testing for raw materials and finished products in a regulated, GMP-compliant environment. This is an opportunity to develop your technical expertise, learn from experienced professionals, and contribute directly to ensuring the quality and safety of products that reach consumers. Position Summary: The Laboratory Technician is responsible for performing basic chemical and/or microbial analysis for one of the assigned QC laboratories (Raw Material, Finished Product, Microbiology, Technical Support) which is responsible for the analysis and disposition of commercial materials (raw materials, finished product release, stability, validation, investigation), and environmental samples, as assigned, documenting results, and maintaining laboratory supplies, chemicals, and logbooks in accordance with SOPs. • Job Type: Full-Time, • Location: Hauppauge, NY, • Works Hours: Monday – Friday, 7:30AM – 3:30PM EST, • Pay Range: $23 per hour, • Start Date: ASAP Responsibilities: include, but are not limited to: • Follow all laboratory SOPs, including but not limited to laboratory safety, chemical handling and storage, gowning, equipment use, cGMP, GDP, data integrity, DEA requirements, etc., • Log in and track all samples received in the lab for testing and release., • Perform laboratory physical chemistry testing (ie. weighing, particle size analysis, LOD, Halogen Moisture Analysis, Moisture Content/KF, Water Activity, etc.), identification testing (ie. FTIR, UV-VIS, TLC) and wet chemistry testing (ie. ICP-OES/MS, DT, titrations, pH, dissolution media/stock sample preparation, laboratory solution preparation and standardization, etc.), as assigned, in accordance with the prescribed approved analytical test method., • Perform sampling, plating, and testing of product assigned for microbiology analysis along with media preparation, sterilization and storage, etc., as assigned in accordance with the prescribed approved test method., • Maintain proper labeling of chemical reagents., • Maintain a clean and organized laboratory working environment., • Assist in laboratory investigations, as assigned., • Dispose of used/expired/excess chemicals, solutions, solvents, etc. in dedicated waste receptacles., • Report well-written, accurate and timely results., • Review data, calculations, notebooks, and reports., • Perform routine Metrology functions, including instrument cleaning/preventive maintenance/ calibration/verification activities., • Monitor and assist with maintaining proper inventory levels of all laboratory supplies., • Assist with sample receiving, chemical inventory, document filing, housekeeping, etc., • Responsible for compliance with all rules and regulations pertaining to safety policies with the proper attitude toward safety and health, helping to ensure that all department operations are performed with the utmost regard for the safety and health for all personnel., • Other responsibilities as assigned by Management.Requirements: Education and Experience: • Associate’s degree or relevant work experience required; Bachelor’s degree preferred. Skills, Knowledge, and Abilities: • Knowledge of laboratory chemistry or microbiology, and cGMPs., • Proficient in Microsoft Word, Excel, graphs/charts and databases., • Able to multitask and meet tight deadlines., • Excellent organizational skills with attention to detail. Physical Demands: • Required to sit and stand for long periods of time., • Frequently reaching with arms/hands up to 2 feet., • Good hand eye coordination., • Occasionally required to walk and kneel., • Must be able to lift and/or move up to 50 pounds., • Must be able to use close vision, distance vision, peripheral vision, color vision and the ability to adjust focus., • Required to reach with arms and use hands and fingers to handle or feel objects, tools and computer controls., • Required to stoop, kneel, crouch, stand, bend, sit, talk, hear, climb stairs. Work Environment: • Work environment in laboratory and production operations facilities include close proximity to heavy machinery and pharmaceutical powders., • Potential to move between production operations sites/areas to complete job functions; regular, ongoing travel throughout geographic areas on a continual basis as normal scope of role requiring use of personal vehicle., • Employee work hours/schedule and/or shift are subject to change based on business needs and Management discretion., • Required to be present in the laboratory to perform daily testing and collaborate with department director, manager, and peers. Supervisory Responsibilities: • None Personal Protective Equipment or Attire Required for Position: • Gowning as required by GMPs and/or SOPs

Job Description Certified Group is committed to partnering with customers to deliver innovative scientific solutions and expertise – So The World Can Trust In What It Consumes™. Our network of 30+ North American and European laboratories serves the food & beverage, dietary supplements, cosmetics, OTC, tobacco/nicotine, cannabis, and hemp industries. Our Brands Certified Group is comprised of a set of specialized brands that collectively deliver laboratory testing, regulatory consulting, and certification & audit services across highly regulated industries: • Certified Laboratories – Provides comprehensive analytical and microbiological testing, primarily supporting food, beverage, cosmetics, OTC, and dietary supplement industries., • Food Safety Net Services (FSNS) – A leading network of ISO-accredited laboratories across North America, focused on food safety testing, operational support, and technical services for the food industry., • Labstat – A global leader in contract research and testing for nicotine, tobacco, cannabis, hemp, and next-generation products, with deep expertise in analytical chemistry and toxicology., • EAS Consulting Group – A regulatory consulting firm offering expert guidance, training, and auditing support across FDA, USDA, and other regulated sectors, powered by a large network of independent advisors., • FSNS Certification & Audit – Provides accredited third-party auditing and certification services, including food safety, animal welfare, and GMP programs. Job Summary: Certified Group is seeking an experienced Microbiology Manager to lead the day-to-day operations of a high-volume microbiology laboratory serving the food and beverage industry. This leadership role is responsible for ensuring the delivery of accurate, timely, and high-quality microbiological testing services while maintaining compliance with ISO 17025 accreditation requirements, regulatory standards, and internal quality systems. The Microbiology Manager will provide both technical and operational leadership, overseeing laboratory workflow, personnel, quality systems, customer satisfaction, financial performance, and continuous improvement initiatives. This individual will foster a culture focused on scientific excellence, safety, accountability, collaboration, and operational efficiency while ensuring the laboratory consistently meets customer expectations and business objectives. This position upholds the Company's purpose, mission, and values by fostering a culture focused on quality, accountability, collaboration, and customer partnership. Purpose: So the world can trust in what it consumes. Mission: Partner with customers to deliver innovative scientific solutions and expertise. Values: Start with the customer, commit to safety and quality, drive to deliver, act with integrity, and support the team. Key Responsibilities • Lead all daily microbiology laboratory operations to ensure quality, efficiency, and turnaround time goals are achieved., • Provide technical oversight for microbiological testing, method validation, quality control, and laboratory investigations., • Maintain compliance with ISO 17025 accreditation standards and applicable regulatory requirements., • Lead internal and external audits, corrective actions, and continuous quality improvement initiatives., • Develop, coach, and mentor laboratory supervisors and technical staff while fostering a high-performing team culture., • Manage staffing, scheduling, productivity, budgets, inventory, and laboratory resources., • Partner with customers and internal stakeholders to ensure exceptional service and technical support., • Drive operational excellence through Lean initiatives, workflow optimization, and performance metrics., • Maintain a safe laboratory environment and ensure compliance with all safety policies and procedures., • Support implementation of new technologies, equipment, and testing capabilities. Qualifications • Bachelor's degree in Microbiology, Biology, Food Science, Food Microbiology, or a related life sciences discipline required; Master's degree preferred., • Minimum of five years of progressive leadership experience within a microbiology laboratory., • Previous experience managing laboratory personnel required., • Experience working in an ISO 17025 accredited laboratory strongly preferred., • Background in food, beverage, dietary supplement, environmental, pharmaceutical, consumer products, or third-party laboratory testing environments preferred., • Strong knowledge of microbiological testing methodologies, laboratory quality systems, and regulatory requirements., • Proven leadership, organizational, analytical, and communication skills., • Experience driving continuous improvement, operational excellence, and team development. Physical Demands & Work Environment • Potential exposure to odors, fumes, airborne particles, hazardous chemicals, and microbiological pathogens., • Required use of personal protective equipment (PPE) within laboratory environments., • Noise levels may vary from quiet to loud depending on operational activity., • Temperature conditions may vary from hot to cold., • Fast-paced, interactive laboratory environment with changing operational demands., • Ability to occasionally lift and/or move up to 25 pounds., • Night and weekend work may be required based on business and customer demands., • Occasional travel may be required. The compensation details provided below reflect the expected pay range for this role, based on the selected compensation structure and applicable guidelines. Actual pay within this range may vary depending on factors such as experience, skills, qualifications, and geographic location. Additional components of total rewards—such as bonuses, benefits, or incentives—may also apply where applicable. Salary Range for Pay Transparency $120,000—$160,000 USD By applying, you acknowledge that Certified Group will process your personal information for recruitment and hiring purposes in accordance with our Applicant Privacy Policy. California residents may review additional information about how we collect and use personal information, including retention and rights, in our California Notice at Collection. To view our Privacy Policy, click the link here: Certified Group Privacy Policy We are an Equal Opportunity Employer and make employment decisions without regard to protected characteristics under applicable law.

Job DescriptionDescription: Position Summary: The Manager of Equipment Maintenance is responsible for supporting assigned production divisions to ensure equipment, documentation, plant, and support systems are repaired, maintained, up to date, and in good working order. Day and Night shift opportunities available. Requirements: Responsibilities: Responsibilities include, but are not limited to: • Develop, execute, and manage equipment maintenance department to meet all requirements and yield a greater than 90% first time right., • Communicate daily with cross-functional department directors and managers., • Troubleshoot and resolve complex equipment issues, driving root cause analysis., • Maintain and process paperwork (internal PO and Vendors) for Accounts Payable., • Evaluate and monitor spare parts to minimize downtime. Monitor and maintain spare parts database, submit requisition for equipment and parts as needed., • Manage relationships with cross-functional teams to install, rebuild, or replace production equipment., • Manage plant maintenance support personnel., • Ensure that technical staff are adequately trained, equipped, and motivated so that technical work can be accomplished in a safe, timely, and cost-effective manner., • Review the operation of plant equipment and systems constantly to minimize unplanned downtime, anticipate and solve problems in a timely manner, and identify opportunities for improvement., • Initiate and carry out projects that improve efficiency and/or reduce operating costs., • Track, analyze and improve key maintenance parameters such as asset utilization, maintenance cost, PM compliance, schedule compliance, etc., • Interface with all equipment monitoring, CMMS, BMS and production/project management software, to plan work activities, and develop interdepartmental feedback, ensuring proper record keeping for maintenance activities., • Perform center lining and 5S work to production lines, product contact parts, and change parts., • Maintain safety, health, and environmental policies and procedures., • Act as role model exemplifying superb ethical conduct and decision making, teamwork, integrity, agility, respect, and accountability., • Other responsibilities as assigned by senior management. Education and Experience: • High school or GED diploma required., • Bachelor’s degree in mechanical engineering, Industrial Maintenance, or related field, or equivalent experience., • 5 years of experience in mechanics and electrical, preferably in a pharmaceutical manufacturing setting; at least 1 year in supervisory or management role. Skills, Knowledge, and Abilities: • Proven leadership experience, with the ability to supervise and motivate a team., • Knowledge of safety regulations, compliance standards, and risk assessment procedures., • Expert knowledge of production equipment and facility’s support systems., • Excellent problem-solving, organizational, and communication skills., • Proficiency in maintenance management software (e.g., CMMS) and Microsoft Office Suite., • Proficient with test equipment, data managing leading to databased decision making., • Strong mathematical/analytical aptitude., • Willingness to lead by example, fostering a shared culture of efficiency with importance on meeting project commitments with on-time completion., • Ability to prioritize and multitask. Physical Demands: • Required to use hands to handle or feel objects, equipment, tools, computer controls and operational machinery., • May be required to lift and/or move up to 50 lbs., stand, bend, kneel, crouch, sit, talk, hear, and walk for a long period., • Specific vision abilities required include close vision, ability to focus. Work Environment: • Work environment in production operations facilities include close proximity to heavy machinery and pharmaceutical powders., • Required to be present in the office to collaborate with executive management, department directors, peers, and supervisors on an as needed basis., • Regular, ongoing travel throughout geographic areas on a continual basis as normal scope of role., • Employee travel/work hours/schedule/location and/or shift are subject to change based on business needs and Management discretion., • Regularly exposed to noise, dust and vibrations in a manufacturing environment; PPE may be required., • Responsible for compliance with all rules and regulations pertaining to safety policies and for leading by example with the proper attitude toward safety and health, helping to ensure that all department operations are performed with the utmost regard for the safety and health for all personnel. Supervisory Responsibilities: • Manage union and nonunion personnel Personal Protective Equipment or Attire Required for Position: • As needed. Pay Range: $80,000 - $100,000 per year

Job Description We are a closed-door specialty pharmacy dedicated to serving patients with complex, chronic, and rare conditions. We partner with providers, payers, and manufacturers to deliver high-touch pharmaceutical care, specialty medication dispensing, and clinical support services — without the retail foot traffic. We're looking for a hands-on Pharmacist in Charge to lead our pharmacy operations, ensure full regulatory compliance, and help us continue delivering exceptional patient outcomes. Position Summary The Pharmacist in Charge (PIC) will hold full legal and operational responsibility for the pharmacy's compliance with state and federal pharmacy law, oversee day-to-day dispensing operations, and lead a team of staff pharmacists and pharmacy technicians. This is a key leadership role for someone who thrives in a specialty pharmacy setting and wants ownership over both clinical quality and operational excellence. Qualifications Active and unrestricted New York Pharmacist license Eligible to serve as Supervising Pharmacist Closed door pharmacy and retail pharmacy experience preferred Strong leadership and compliance mindset Great pay and bonus structure

Job Description Position Summary A growing dietary supplement manufacturer and packaging company is seeking an experienced, hands-on quality leader to direct its Quality Unit. The Director of Quality Assurance & Regulatory Compliance will have primary responsibility for the company's cGMP quality management system, NSF certification, regulatory inspection readiness, and product-quality decisions. This individual will serve as the company's principal representative during NSF, FDA, customer, and third-party audits and will have independent authority to place materials and products on hold, approve or reject materials and finished batches, require corrective action, and escalate quality or regulatory risks directly to senior management. Primary Responsibilities • Own and continuously improve the site Quality Management System in accordance with 21 CFR Part 111, applicable provisions of 21 CFR Part 117, NSF/ANSI 455-2, company procedures, and other applicable requirements., • Serve as the primary host and company representative for NSF, FDA, customer, and third-party audits and inspections., • Maintain continuous inspection readiness and manage audit preparation, responses, corrective actions, and timely closure of findings., • Establish, maintain, and approve quality procedures, specifications, controls, and records covering manufacturing, packaging, labeling, laboratory, and warehouse operations., • Review and approve master manufacturing records, batch production records, and relevant changes before implementation., • Exercise final Quality Unit authority over quarantine, release, rejection, reprocessing, and disposition of raw materials, packaging components, labels, in-process materials, and finished products., • Lead investigations involving deviations, nonconformances, out-of-specification results, foreign objects, contamination risks, and other unanticipated occurrences., • Own root-cause analysis, CAPA, change control, and effectiveness-verification programs., • Oversee supplier qualification and requalification, COAs, raw-material specifications, incoming-material controls, and applicable vendor quality agreements., • Oversee internal QC laboratory activities and external laboratory relationships, including sampling plans, scientifically valid methods, testing, data review, calibration, validation, stability, and reserve-sample programs., • Ensure documentation and data meet cGMP requirements for accuracy, completeness, traceability, and contemporaneous recording., • Direct complaint, return, adverse-event quality investigation, recall, and mock-recall processes in coordination with senior management and counsel., • Review product labels, Supplement Facts panels, ingredient declarations, and relevant product claims for regulatory compliance in collaboration with Product Development, Marketing, and legal counsel., • Support retailer and marketplace compliance requirements, including GMP certificates, COAs, laboratory documentation, and manufacturer relationship documentation., • Maintain applicable facility registrations, certifications, regulatory correspondence, and audit calendars., • Establish and monitor quality metrics, recurring management reviews, internal audit programs, and compliance-risk reporting., • Develop and deliver cGMP training for manufacturing, packaging, warehouse, laboratory, and administrative personnel., • Lead, coach, and develop Quality Assurance and Quality Control employees while promoting accountability, respectful communication, and constructive cross-functional problem solving., • Build documented succession and cross-training within the Quality Unit to eliminate single-person dependency for critical compliance functions. Authority The Director of Quality Assurance & Regulatory Compliance will have: • Independent authority to quarantine, hold, approve, reject, release, or require further investigation of materials and products., • Authority to stop or restrict an operation when product quality, consumer safety, or regulatory compliance may be compromised., • Direct and unrestricted access to senior executive leadership for material quality or compliance concerns., • Quality responsibilities organizationally distinct from Production and Manufacturing. Required Qualifications • Bachelor's degree in chemistry, biochemistry, pharmaceutical science, microbiology, food science, chemical engineering, or a related discipline, or an equivalent combination of education and directly relevant experience., • At least 8 years of progressive quality experience in dietary supplement, nutraceutical, food, or pharmaceutical manufacturing, with substantial direct dietary supplement experience strongly preferred., • At least 3 years leading a Quality Assurance, Quality Control, or regulatory compliance function., • Expert working knowledge of 21 CFR Part 111 and practical experience applying its requirements within a manufacturing facility., • Direct experience preparing for and personally leading NSF/ANSI 455-2, FDA, or comparable dietary supplement manufacturing audits and inspections., • Demonstrated experience with QMS administration, SOPs, document control, CAPA, deviations, OOS investigations, change control, supplier qualification, batch review, and product disposition., • Experience with tablet and capsule manufacturing and dietary supplement packaging operations., • Experience overseeing internal and third-party laboratory testing, COA review, and scientifically valid analytical or microbiological methods., • Strong written communication, documentation, judgment, and audit-room leadership skills., • Demonstrated ability to communicate respectfully and constructively with employees at every level of an organization. Preferred Qualifications • Master's degree in a relevant scientific discipline., • ASQ Certified Quality Auditor, Certified Manager of Quality/Organizational Excellence, or comparable credential., • NSF/ANSI 455-2 auditor training., • HACCP, PCQI, FSVP, food-defense, or recall-coordinator training., • Experience with USDA Organic, Amazon dietary supplement verification, or other retailer compliance programs., • Experience using ERP, electronic QMS, document-control, or LIMS systems. A Ph.D. is welcome but not required. Demonstrated dietary supplement cGMP leadership and successful audit experience are more important than academic credentials.

Job DescriptionDescription: We are seeking a Serialization Engineer to join our Operations team, where you’ll play a key role in supporting serialized packaging operations and technical packaging solutions across pharmaceutical products. In this hands-on, cross-functional role, you’ll work closely with Packaging, Quality, Engineering, and project teams to ensure efficient, compliant, and accurate packaging operations from inception through commercial launch. This is an excellent opportunity for someone who enjoys solving technical challenges, learning new serialization technologies, and contributing directly to high-quality pharmaceutical packaging processes. Job Type: Full-Time Location: Hauppauge, NY Works Hours: Monday – Friday, 9:00AM – 5:00PM Pay Range: $75,000 - $100,000 per year, depending on experience Start Date: ASAP What makes this role exciting: • Hands-on with cutting-edge serialization technology – work directly with Optel Linemaster, Pharmaproof, and other packaging automation systems., • Learn and grow in a fast-paced pharmaceutical environment – gain exposure to packaging design, commissioning, validation, and regulatory compliance., • Cross-functional experience – collaborate with Engineering, Quality, Project Management, and technical teams to see projects from concept to commercial launch., • Impactful work – your contributions directly support product integrity, consumer safety, and regulatory compliance. Why Join CPC? At CPC, you’ll be part of a team that has set the standard in pharmaceutical development and contract manufacturing since 1971, helping bring high-quality OTC, dietary supplement, and prescription products to market faster and safer than ever. We pride ourselves on quality as a core value, innovative problem-solving, and a collaborative culture where everyone plays a role in advancing formulation and manufacturing excellence. CPC offers an inclusive, respectful workplace with opportunities to grow your skills and career while working with cutting-edge technologies and serving leading global brands. With a commitment to employee success, competitive benefits, and a culture built on teamwork and integrity, CPC is a place where your contributions truly make an impact. Requirements: Responsibilities In this role, you will: • Support serialized packaging projects from start to launch by assisting in equipment commissioning, validation, and process optimization for new and existing packaging configurations., • Conduct line trials, studies, and assessments to determine critical process parameters (CPP) and ensure consistent, compliant packaging operations., • Administer serialization operations including serial number management, master recipe creation, EPCIS updates, and shipment event notifications., • Collaborate cross-functionally with Packaging, Engineering, Quality, Project Management, and Business Development teams to solve technical challenges and implement process improvements., • Develop and maintain technical documentation including SOPs, setup sheets, P&IDs, and packaging engineering reports to support compliance and operational excellence. Education & Experience • Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Manufacturing Engineering, or a related technical discipline required, • Minimum 3 years of relevant experience in engineering, packaging or serialization roles, preferably in a pharmaceutical environment, • Hands-on experience with packaging equipment, line trials, and process validation strongly preferred, • Experience with AutoCAD, MS Excel, MS Project, or other engineering software Skills, Knowledge & Abilities • Knowledge of Pharmaceutical Serialization and Aggregation systems and DSCSA guidelines, • Familiarity with FDA, cGMP, and 21 CFR Part 210, 211, and Part 11, • Strong technical writing and documentation skills, • Hands-on knowledge of packaging equipment setup, operation, and maintenance, • Ability to read and develop engineering drawings, P&IDs, and technical documentation, • Strong problem-solving skills and ability to work in cross-functional teams

Job DescriptionBenefits: • 401(k), • Health insurance, • Paid time off, • 401(k) matching, • Bonus based on performance Job description: Senior Scientist (R&D) is responsible for method development, validation, and analytical support activities for dietary supplements/pharmaceutical raw materials and finished products in a fast‑paced environment. This role requires strong technical expertise in chromatographic and spectroscopic techniques, regulatory understanding, and the ability to guide junior scientists MAJOR DUTIES/RESPONSIBILITIES: • Method Development: Develop and optimize analytical methods (HPLC/UPLC, GC‑FID, LC‑MS/MS, GC‑MS/MS, ICP‑OES, ICP‑MS, IC, etc.) for raw materials and finished products. This includes developing and optimizing sample‑preparation procedures for complex‑matrix finished forms., • Method Validation: Perform and document method validation/verification per USP and ICH Q2(R2) guidelines., • Instrument Troubleshooting: Maintain and troubleshoot analytical instruments; ensure calibration and qualification compliance., • Mentor junior chemists, train staff, and support work planning., • Perform other duties as assigned.MINIMUM/PREFERRED REQUIREMENTS: Education: • Master’s / Ph.D. degree in chemistry, science or Pharmaceutics.Experience:, • MS/Ph.D. with 5+ years of experience in a dietary supplements/pharmaceutical analytical development lab., • Must have good understanding of cGMPs and able to author quality investigations., • Proficient in using softwares (such as Empower, openlab, Masshunter, Masslynx etc.) including custom field calculations.Job Type: Full-time Pay: Starting at $90,000.00 per year Physical Requirements: • Ability to lift and move equipment weighing up to 50 pounds., • Manual dexterity for handling small tools and instruments.Job Type: Full-time

Job DescriptionDescription: Position Summary The Senior Chemist is responsible for and has an advanced level of experience in performing chemical analysis for one of the assigned QC laboratories (Raw Material, Finished Product, Technical Support) which is responsible for the analysis and disposition of commercial materials (raw materials, finished product release, stability, validation, investigation), and environmental samples, as assigned, and documenting results in accordance with SOPs. Requirements: Responsibilities: Responsibilities include, but are not limited to: • Follow all laboratory SOPs, including but not limited to laboratory safety, chemical handling and storage, gowning, equipment use, cGMP, GDP, data integrity, DEA requirements, etc., • Perform laboratory chemical analysis on raw materials, in-process materials, and/or finished product, using ICP-OES/MS, UV-Vis, Fluorescence, GC, HPLC/UPLC, titration, and other wet chemistry techniques, as assigned, in accordance with the prescribed approved analytical test method., • Execute assay testing, content uniformity testing, impurities analysis, validation testing (method, cleaning, process), and process/interpret data at an advanced level with minimal to no errors., • Maintain clean and organized laboratory working environment., • Disposes of used/expired/excess chemicals, solutions, solvents, etc. in dedicated waste receptacles., • Report well-written, accurate and timely results., • Review data, calculations, notebooks, and reports., • Perform and assist in laboratory investigations., • Perform and assist in Cleaning, Method and Process validation testing and protocol/report review., • Maintain and troubleshoot laboratory equipment at an advanced level., • Suggest improvements to existing testing methods when possible., • Mentor and train entry-level and mid-level personnel on techniques performed in the lab and assist with laboratory related questions as needed., • Assist with routine Metrology functions, including instrument cleaning/ preventive maintenance/ calibration/ verification activities., • Monitor and assist with maintaining proper inventory levels of all laboratory supplies., • Assist with sample receiving, chemical inventory, document filing, housekeeping, etc., • Responsible for compliance with all rules and regulations pertaining to safety policies with the proper attitude toward safety and health, helping to ensure that all department operations are performed with the utmost regard for the safety and health for all personnel., • Other responsibilities as assigned by Management. Education and Experience: • Bachelor’s degree in a science related field., • At least 8 years of work experience in a laboratory setting preferred. Skills, Knowledge, and Abilities: • Proficient in laboratory chemistry and cGMPs., • Proficient in Microsoft Word, Excel, graphs/charts and databases., • Advanced level experience in HPLC/UPLC, ICP, Dissolution, IR, UV/VIS, and wet chemistry testing., • Advanced level experienced with analytical laboratory software., • Able to multitask and meet tight deadlines., • Excellent organizational skills with attention to detail., • Able to effectively present results., • Able to independently perform testing on all methods and troubleshoot most method issues with little or no help., • Able to independently troubleshoot complex instrument issues with little or no help. Physical Demands: • Required to sit and stand for long periods of time., • Frequently reaching with arms/hands up to 2 feet., • Good hand eye coordination., • Occasionally required to walk and kneel., • Must be able to lift and/or move up to 50 pounds., • Must be able to use close vision, distance vision, peripheral vision, color vision and the ability to adjust focus., • Required to reach with arms and use hands and fingers to handle or feel objects, tools and computer controls., • Required to stoop, kneel, crouch, stand, bend, sit, talk, hear, climb stairs. Work Environment: • Work environment in laboratory and production operations facilities include close proximity to heavy machinery and pharmaceutical powders., • Potential to move between production operations sites/areas to complete job functions; regular, ongoing travel throughout geographic areas on a continual basis as normal scope of role requiring use of personal vehicle., • Employee work hours/schedule and/or shift are subject to change based on business needs and Management discretion., • Required to be present in the laboratory to perform daily testing and collaborate with department director, manager, and peers. Supervisory Responsibilities: · None Personal Protective Equipment or Attire Required for Position: · Gowning as required by GMPs and/or SOPs. Pay Range: $90,000 - $100,000 per year

Job DescriptionDescription: Position Summary: The Chemist II is responsible for and has a moderate level of experience in performing chemical analysis for one of the assigned QC laboratories (Raw Material, Finished Product, Technical Support) which is responsible for the analysis and disposition of commercial materials (raw materials, finished product release, stability, validation, investigation), and environmental samples, as assigned, and documenting results in accordance with SOPs. Responsibilities: Responsibilities include, but are not limited to: • Follow all laboratory SOPs, including but not limited to laboratory safety, chemical handling and storage, gowning, equipment use, cGMP, GDP, data integrity, DEA requirements, etc., • Perform laboratory chemical analysis on raw materials, in-process materials, and/or finished product, using ICP-OES/MS, UV-Vis, Fluorescence, GC, HPLC/UPLC, titration, and other wet chemistry techniques, as assigned, in accordance with the prescribed approved analytical test method., • Execute assay testing, content uniformity testing, impurities analysis, method transfers, cleaning validation testing, and process/interpret data at a moderate level with minimal to no errors., • Maintain a clean and organized laboratory working environment., • Dispose of used/expired/excess chemicals, solutions, solvents, etc. in dedicated waste receptacles., • Report well-written, accurate and timely results., • Review data, calculations, notebooks, and reports., • Assist in laboratory investigations, as assigned., • Assist in Process validation testing and protocol/report review, as assigned., • Maintain and troubleshoot laboratory equipment at a moderate level., • Suggest improvements to existing testing methods when possible., • Assist with routine Metrology functions, including instrument cleaning/ preventive maintenance/ calibration/ verification activities., • Monitor and assist with maintaining proper inventory levels of all laboratory supplies., • Assist with sample receiving, chemical inventory, document filing, housekeeping, etc., • Responsible for compliance with all rules and regulations pertaining to safety policies with the proper attitude toward safety and health, helping to ensure that all department operations are performed with the utmost regard for the safety and health for all personnel., • Other responsibilities as assigned by Management.Requirements: Education and Experience: • Bachelor’s degree in a science related field., • Between 4 - 8 years of work experience in a laboratory setting preferred. Skills, Knowledge, and Abilities: • Knowledge of laboratory chemistry and cGMPs., • Proficient in Microsoft Word, Excel, graphs/charts and databases., • Proficient in HPLC/UPLC, ICP, Dissolution, IR, UV/VIS, and wet chemistry testing., • Proficient with analytical laboratory software., • Able to multitask and meet tight deadlines., • Excellent organizational skills with attention to detail., • Able to effectively present results., • Able to perform testing on moderate level methods and troubleshoot moderate method issues. May require some guidance/supervision as needed., • Able to troubleshoot moderate instrument issues independently, and complex instrument issues under supervision. Physical Demands: • Required to sit and stand for long periods of time., • Frequently reaching with arms/hands up to 2 feet., • Good hand eye coordination., • Occasionally required to walk and kneel., • Must be able to lift and/or move up to 50 pounds., • Must be able to use close vision, distance vision, peripheral vision, color vision and the ability to adjust focus., • Required to reach with arms and use hands and fingers to handle or feel objects, tools and computer controls., • Required to stoop, kneel, crouch, stand, bend, sit, talk, hear, climb stairs. Work Environment: • Work environment in laboratory and production operations facilities include close proximity to heavy machinery and pharmaceutical powders., • Potential to move between production operations sites/areas to complete job functions; regular, ongoing travel throughout geographic areas on a continual basis as normal scope of role requiring use of personal vehicle., • Employee work hours/schedule and/or shift are subject to change based on business needs and Management discretion., • Required to be present in the laboratory to perform daily testing and collaborate with department director, manager, and peers. Supervisory Responsibilities: • None Personal Protective Equipment or Attire Required for Position: • Gowning as required by GMPs and/or SOPs. Pay Range: • $75,000 - $89,999 per year

Job DescriptionDescription: A Material Handler is responsible for limited material movement and general handling before, during, and after manufacturing and\or packaging runs and\or in warehouse. *Multiple Shifts Available - Day, Night, Weekend - Full & Part Time Opportunities Requirements: Responsibilities: Responsibilities include, but are not limited to: • Bringing raw material to the production line, in-process material to the next process step, • Packing finished product onto pallets or similar general material handling, • Maintaining a clean and organized workstation, • Assist Line Leaders\Setup Techs with general cleaning and whenever help is required, • Assist Machine Operator in end of run procedures, • Notify management of any quality or safety concerns, • Training and compliance with general procedures and applicable company policies such as Good Hygiene Practice, current Good Manufacturing Practice (cGMP), and related Standard Operating Procedures (SOP), • Responsible for compliance with all rules and regulations pertaining to safety policies and leading by example with the proper attitude toward safety and health. Help to ensure that all department operations are performed with the utmost regard for the safety and health for all personnel., • Other responsibilities as assigned by management Education and Experience: • High School or GED diploma preferred., • Work experience in GMP environment a plus., • Experience in pharmaceutical production environment a plus. Skills, Knowledge and Abilities: • Ability to comprehend, follow and accurately perform all instructions detailed in batch production record., • Ability to work independently., • Ability to learn and utilize ERP system (DEACOM)., • Experience with warehouse equipment a plus. Physical Demands: • Required to use hands to handle or feel objects, tools, computer controls, equipment., • While performing the duties of this job, the employee is regularly required to stoop, kneel, crouch, climb, stand, bend, sit, talk, hear, or walk for prolonged periods. The employee may lift, move and or carry up to 50 lbs., • Specific vision abilities required include close vision, distance vision, peripheral vision, color vision and the ability to adjust focus. Work Environment: • Work environment in production operations facilities include close proximity to heavy machinery and pharmaceutical powders (dust), with loud noises., • Required to be present at designated facilities to provide immediate departmental support daily., • Employee travel/work hours/schedule/location and/or shift are subject to change based on business needs and management discretion., • Regular, ongoing travel throughout geographic areas on a continual basis as normal scope of role. Personal Protective Equipment Required for Position: • PPE / GMP gowning Qualifications: • Work experience in GMP environment a plus Pay Range*: • Material Handler: $17.00 - $19.75 / hour *Ranges indicated account for all shifts. Please indicate your shift preference when applying.

Job DescriptionLNK International, Inc. is one of the nation's largest manufacturers of solid and liquid dose, over the counter (OTC) pharmaceuticals. For over 40 years, we have built a reputation for delivering the highest quality products, outstanding service and product innovation.What sets LNK apart? We believe it is our employees. There is a commitment to quality in every department at LNK. As a member of our team you will be working with dedicated professionals who support and interact with all areas of the company. Our full time employees enjoy competitive benefits including:401(k) with generous employer matchHealth InsuranceDental InsurancePaid holidays Paid vacationThe Packaging Maintenance Mechanic is responsible for the setup, maintenance, troubleshooting, repair, and preventative maintenance of packaging equipment used in the production of over-the-counter (OTC) pharmaceutical products. This position ensures packaging lines operate safely, efficiently, and in compliance with current Good Manufacturing Practices (cGMP), FDA regulations, and company quality standards. The mechanic works closely with Packaging, Quality Assurance, Engineering, and Production teams to minimize downtime and maximize equipment reliability. Essential Duties and ResponsibilitiesSet up, adjust, and prepare packaging equipment and packaging lines for production runs. Maintain and perform preventative maintenance on all packaging equipment according to established schedules and procedures. Troubleshoot and repair packaging equipment during production runs to minimize downtime and maintain production efficiency. Diagnose mechanical, pneumatic, hydraulic, and electrical issues on packaging machinery. Understand and follow all Standard Operating Procedures (SOPs), work instructions, and maintenance curriculums applicable to the position. Perform changeovers, equipment adjustments, and line clearances in accordance with production schedules. Document maintenance activities, repairs, and preventative maintenance tasks accurately and completely. Assist with equipment installation, validation, and qualification activities as required. Ensure compliance with cGMP, FDA, OSHA, and company safety requirements. Collaborate with Production and Quality departments to resolve equipment-related issues affecting product quality. Work in conjunction with the Parts Room for spare parts inventory and notify management of parts requirements. Participate in continuous improvement initiatives to increase equipment reliability and operational efficiency. Maintain a clean and organized work area in accordance with company housekeeping standards. Respond to emergency equipment breakdowns and perform corrective maintenance as needed. Assist in training production operators on proper equipment operation and basic troubleshooting techniques. Perform all other duties as assigned. Required QualificationsHigh school diploma or GED required; technical school or vocational training preferred. Minimum of 3 years of maintenance experience in a manufacturing environment, preferably within pharmaceutical, food, cosmetic, or consumer packaged goods industries. Experience in maintaining and troubleshooting packaging equipment, such as: Bottle fillers Cappers Labelers Cartoners Blister packaging machines Case packers Conveyors Serialization and coding equipment Vision inspection systems Inkjet codersStrong mechanical aptitude and troubleshooting skills. Ability to read and interpret mechanical drawings, equipment manuals, and technical documentation. Basic understanding of electrical systems, sensors, and automated controls. Knowledge of pneumatic and hydraulic systems. Knowledge, Skills, and AbilitiesStrong troubleshooting and problem-solving abilities. Excellent attention to detail and documentation skills. Ability to prioritize multiple tasks in a fast-paced manufacturing environment. Strong communication and teamwork skills. Commitment to safety, quality, and regulatory compliance. Physical RequirementsAbility to stand, walk, bend, kneel, and climb for extended periods. Ability to lift and carry up to 50 pounds. Ability to work around moving machinery and manufacturing equipment. Ability to wear required personal protective equipment (PPE). Work EnvironmentManufacturing and packaging facility environment. Exposure to moving mechanical parts, cleaning chemicals, noise, and varying temperatures. Overtime, weekends, and off-shift work may be required to support production schedules and equipment maintenance needs. The salary listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future. When determining a team member's base salary and/or rate, several factors may be considered as permitted by law. LNK provides equal employment opportunities to all applicants and prohibits discrimination of any type on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information or any other characteristic protected by applicable federal, state or local laws. Job Posted by ApplicantPro

As a Roll Attendant, you will set up and operate assigned packaging machines to pre-established specifications. He/She will ensure they pack the optimum number of quality packages of product, in accordance with all safety, SOPs and cGMP guidelines and procedures. Responsibilities: • Set-up and manage machines to perform at the desired, pre-established requirements., • Ensure machine operates in accordance with the guidelines of the company., • Ability to hoist roll of nonwovens on to machine., • Troubleshoot equipment and remove jams when necessary., • Oversee the machines while they execute the tasks and make the necessary changes to produce improved results., • Capacity to use a hand jack to move liquid totes to the machine., • Check machinery on a daily basis to guarantee functionality., • Produce High Quality finished goods (At All Times), • Maintain a clean and safe work area., • Perform all other duties as assigned which may become necessary to support departmental/organizational objectives. Qualifications: • High School degree or GED, desired., • Basic math and command of English reading and writing., • Prior working knowledge in a manufacturing, packaging, or pharmaceutical industry, preferred., • Must be able to safely operate the machine for the intended purpose., • Must be able to keep up with the line speed of machinery., • Ability to lift repetitively, and meet volume demand etc., • Flexibility in work schedule, based on volume needs, which could require weekends and/or working overtime during high demand., • Understand, follow, and ensure compliance with Good Manufacturing Practices (cGMP) and adherence to defined procedures, safety rules and SOPs., • Ability to work in various weather/temperature conditions to include heat, humidity and cold., • Comfortable working in a fast-paced and loud production environment., • Ability to work as part of a team and follow directions., • Attention to details. Physical Demands: • Ability to frequently lift/move/pull heavy objects up to 70 lbs., • Constant manual dexterity use., • Required to stand for long period of time. Work Environment: • Work is performed primarily in a laboratory and manufacturing environment where exposure to biological agents, chemicals, and disinfectants may occur., • The role requires adherence to all safety procedures, including the use of PPE and compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP)., • The noise level in the work environment is generally moderate but may vary depending on production activity., • The laboratory environment is temperature-controlled, but occasional work in production or warehouse areas may be required., • The employee must maintain a clean, organized, and safe workspace in accordance with company and regulatory standards. Shift A Schedule: Monday to Thursday 6:00am-6:00pm (1 position) Shift B Schedule: Monday to Thursday 6:00pm-6:00am(1 position) Shift D Schedule: Friday-Sunday 6pm-6am (1 position) Why Join Us? At Radienz Living, we take pride in making high-quality personal care and household products that people trust every day. As part of our team, you'll join a company that values safety, teamwork, and continuous improvement. We believe in investing in our people providing hands-on experience, training, and opportunities to grow your career in manufacturing, quality, and operations. You'll work in a clean, professional, and collaborative environment where your contributions make a direct impact on the products we deliver to leading brands and consumers. At Radienz Living, we're more than a manufacturing company we're a community built on respect, reliability, and shared success. The approximate hourly pay for this position is $19.04*. Please note that the pay range provided is a good faith estimate for the position at the time of posting. Final compensation may vary based on factors including but not limited to knowledge, skills and abilities as well as geographic location. Radienz Living is an equal employment opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status or any other characteristic protected by applicable law. Prior to the next step in the recruiting process, we welcome you to inform us confidentially if you may require any special accommodation to participate fully in our recruitment experience. Contact us at 631-52-0100 Ext. 3045 The company participates in the E-Verify program to confirm the employment eligibility of all new hires. This position is not eligible for Visa Sponsorship.

Job DescriptionDescription: Position Summary: The Administrative Assistant is responsible for assisting the QC Manager in one of the assigned QC laboratories (Raw Material, Finished Product, Microbiology, ICP, Technical Support) with any tasks including, but not limited to, maintenance of laboratory documentation, initiation of laboratory change controls, and direct communication and coordination between all internal departments. Responsibilities: Responsibilities include, but are not limited to: • Preparation and review of the certificate of analysis (CofA) for all materials tested. Includes review of testing results reported and manufacturing batch records, as required., • Communicate and provide information to other departments, as requested., • Coordinate with the Regulatory Affairs group to maintain and update specifications as required based on regulation requirements and changes., • Manage and support the laboratory by initiating change controls, drafting revisions to QC documentation (specifications, test methods, SOPs, etc.), and completing action items within the electronic quality management system., • Maintain current and retired QC documents., • Maintain spreadsheets for tracking departmental metrics, laboratory performance, and material release., • Monitor and maintain proper inventory levels of all laboratory supplies and reagents by working with the laboratory and purchasing groups., • Interact with all outside contract laboratories used for testing of samples., • Assist with and coordinate distribution of documents, procedures, instructions, and training., • May be required to assist in performing basic related tests, as needed., • Other responsibilities as assigned by Management.Requirements: Education and Experience: • Associate’s degree preferred; equivalent years’ work experience is acceptable. Skills, Knowledge, and Abilities: • Proficiency in Microsoft Word, Excel, graphs/charts and databases., • Ability to multitask and meet tight deadlines., • Excellent organizational and follow-up skills with attention to detail., • Ability to communicate effectively. Physical Demands: • Required to sit and stand for long periods of time., • Frequently reaching with arms/hands up to 2 feet., • Good hand eye coordination., • Occasionally required to walk and kneel., • Must be able to lift and/or move up to 50 pounds., • Must be able to use close vision, distance vision, peripheral vision, color vision and the ability to adjust focus., • Required to reach with arms and use hands and fingers to handle or feel objects, tools and computer controls., • Required to stoop, kneel, crouch, stand, bend, sit, talk, hear, climb stairs. Work Environment: • Work environment in laboratory and production operations facilities include close proximity to heavy machinery and pharmaceutical powders., • Potential to move between production operations sites/areas to complete job functions., • Employee work hours/schedule and/or shift are subject to change based on business needs and Management discretion., • Required to be present in the laboratory to perform daily testing and collaborate with department director, manager, and peers., • Responsible for compliance with all rules and regulations pertaining to safety policies with the proper attitude toward safety and health, helping to ensure that all department operations are performed with the utmost regard for the safety and health for all personnel. Supervisory Responsibilities: • None Personal Protective Equipment or Attire Required for Position: • Gowning as required by GMPs and/or SOPs. Pay Range: $21 per hour