Quality Specialist
hace 10 días
Grand Rapids
Job DescriptionJob Title: Quality Specialist Job Description The Quality Specialist will lead and manage the quality function for a small, growing pharmaceutical manufacturing organization. This role establishes, maintains, and continuously improves the Quality Management System (QMS) while ensuring full compliance with FDA and other applicable regulatory requirements. The position is ideal for a hands-on quality assurance professional who can independently manage quality operations, oversee validation activities, support internal and external laboratory operations, and serve as the primary point of contact with regulatory authorities, including the FDA. Responsibilities • Own and administer the company’s Quality Management System (QMS), including standard operating procedures (SOPs), deviations, corrective and preventive actions (CAPAs), change control, complaints, and documentation control., • Ensure ongoing compliance with FDA current Good Manufacturing Practice (cGMP) regulations (21 CFR Parts 210/211) and other applicable regulatory standards., • Act as the quality authority for manufacturing, laboratory, and validation-related decisions, providing clear guidance and oversight., • Serve as the primary contact for regulatory agencies, including leading interactions during FDA inspections, customer audits, and third-party audits., • Lead regulatory inspections from preparation through hosting and follow-up, including coordination of on-site activities and communication with internal stakeholders., • Prepare, review, and approve regulatory responses such as FDA Form 483 responses, warning letter remediation plans, and audit-related CAPAs., • Lead and oversee process validation activities, including process performance qualification (PPQ) planning, protocol development, execution, and final reporting., • Own the cleaning validation strategy and execution, including conducting risk assessments, developing protocols, defining sampling plans, and authoring final reports., • Partner closely with Manufacturing and Technical Operations to ensure processes are validated, compliant, and maintained in a state of control., • Provide quality oversight of internal laboratory operations, including testing practices, data integrity, documentation, and adherence to SOPs and cGMP expectations., • Manage and qualify external laboratory partners, contract laboratories, and service providers to ensure compliance with quality and regulatory standards., • Review and approve analytical data, investigations, method validations and transfers, and stability programs as applicable., • Provide routine quality support to manufacturing operations, including batch record review, deviation investigations, and change management activities., • Ensure manufacturing processes align with validated states and GMP expectations, escalating and resolving quality issues as needed., • Support new product introductions, technology transfers, and scale-up activities from a quality perspective, ensuring compliance throughout the product lifecycle., • Contribute to and drive continuous improvement initiatives within the quality system, manufacturing processes, and laboratory practices., • Lead and influence the development of the quality culture within the organization as the head of the quality function in a small but growing pharmaceutical operation.Essential Skills, • Proven experience in quality assurance within a pharmaceutical manufacturing environment., • Strong knowledge of FDA regulations and current Good Manufacturing Practices (cGMP), including 21 CFR Parts 210/211., • Demonstrated experience owning and administering a Quality Management System (QMS), including SOPs, deviations, CAPAs, change control, complaints, and documentation control., • Hands-on experience supporting and overseeing validation activities, including process validation and cleaning validation., • Experience providing quality oversight to laboratory operations, including testing practices, data integrity, and documentation., • Experience managing and interacting with regulatory authorities, including FDA inspections, audits, and regulatory correspondence., • Ability to act as the quality authority for manufacturing, laboratory, and validation-related decisions., • Strong understanding of quality control, auditing practices, and compliance in a pharmaceutical setting., • Ability to interpret and apply SOPs, cGMP, and other regulatory and compliance requirements., • Excellent written and verbal communication skills for preparing and reviewing regulatory responses, protocols, and reports., • Strong organizational skills with the ability to independently manage multiple quality operations and priorities.Additional Skills & Qualifications, • Experience leading regulatory inspections (FDA, customer, or third-party), including preparation, hosting, and response activities., • Experience preparing, reviewing, and approving 483 responses, warning letter remediation plans, and audit CAPAs., • Background in process performance qualification (PPQ) planning, execution, and reporting., • Experience developing and executing cleaning validation strategies, including risk assessments, protocols, and sampling plans., • Experience managing and qualifying external laboratory partners, contract labs, and service providers., • Experience reviewing and approving analytical data, investigations, method validations and transfers, and stability programs., • Experience supporting new product introductions, technology transfers, scale-up activities, and continuous improvement initiatives., • Demonstrated leadership in quality system development and quality culture building within a small or growing organization., • Familiarity with pharmaceutical manufacturing operations and technical operations collaboration.Work Environment This role is based on-site in a small pharmaceutical manufacturing space and office environment, offering close collaboration with manufacturing, laboratory, and technical operations teams. The typical work schedule is Monday through Friday from 7:00 a.m. to 4:00 p.m. The setting combines office-based responsibilities, such as documentation and regulatory correspondence, with regular presence on the manufacturing floor and in laboratory areas to provide hands-on quality oversight and support. Job Type & Location This is a Contract to Hire position based out of Grand Rapids, MI. Pay and Benefits The pay range for this position is $40.00 - $50.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program, • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Grand Rapids,MI. Application Deadline This position is anticipated to close on Jun 6, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.
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