Microbiology Analyst I
hace 14 horas
Mount Laurel
Job Description Why Stokes? Stokes Healthcare is a privately-owned business comprised of three divisions: Stokes Pharmacy (503A pharmacy), Epicur Pharma (503B facility) and STEP labs. The these divisions operate out of separate facilities in Mount Laurel, NJ, following different regulations and are guided by different principles. Stokes Pharmacy was founded in 1975. The pharmacy formulates custom prescription medicines for both humans and animals. The business has grown from a small, hometown operation in Medford, New Jersey, to a respected pharmacy serving the entire U.S., enabled by sophisticated online ordering and overnight shipping capabilities. In 2016, Stokes Healthcare built a world-class facility (which became Epicur Pharma), as a testament to the commitment to providing the highest level of quality. Adding a unique offering to the veterinary industry, Epicur Pharma is an FDA Registered 503B Outsourcing Facility, producing drugs such as Tacrolimus Eyedrops, Buprenorphine Injection and Gabapentin tablets. Epicur follows Current Good Manufacturing Practices (cGMP) which are the same rules and regulations followed by commercial manufacturers. Epicur Pharma is proud to be a pioneer in animal drug standards, offering the largest selection of manufactured drugs that are traditionally compounded. Epicur products are distributed directly to veterinary hospitals from our manufacturing facility and offered through Stokes Pharmacy for individual patient prescriptions. STEP Labs is a GMP-compliant laboratory that delivers accurate, reliable analytical testing for manufactured pharmaceutical products. Equipped with advanced instrumentation and operated under strict regulatory standards, STEP Labs provides comprehensive services in microbiological and chemistry analysis with a focus on quality, data integrity, and timely results. Stokes Healthcare has built a reputation for unwavering quality and superb service by holding fast to the founders’ commitment to traditional craftsmanship, combined with today’s most advanced knowledge and technologies. In a field where many corporate-owned pharmacies try to compete on price, Stokes has always put safety and quality first because patients’ lives depend on it. At Stokes, we offer competitive salaries and a comprehensive benefits package that includes medical, dental and vision coverage, life insurance, Health Reimbursement Account, Flexible Spending Account, 401(K) retirement savings plan with a generous employer match, a bonus program, paid holidays, vacation and personal time, and an excellent working environment. We are conveniently located in Mount Laurel, New Jersey, just minutes from Philadelphia and the NJ shore. Job Title Microbiology Analyst I FLSA Status Non-exempt Job Summary The Microbiology Analyst I is responsible for supporting microbiology procedures, assisting in investigations, and performing routine analysis of raw material and finished product according to established specifications and procedures. Starting at $20/hour based on experience plus twice a year cash bonuses. Essential Duties and Responsibilities include the following. Other duties may be assigned. • Assist in method validation for sterility, bioburden, and endotoxin of drug products including, but not limited to, injections, ophthalmic preparations, oral tablets, and oral liquids, • Perform and/or assist in investigations related to sterility assurance and environmental monitoring, • Perform routine analysis of finished product and raw material according to established specifications and procedures relating to:, • Sterility, • Bioburden, • Endotoxin, • AET, • Growth Promotion, • Perform atypical particulate inspection on finished product, • Support sampling and microbiological testing on facility water (WFI, CS, etc.), • Review and approve data related to sterility, bioburden, AET, and endotoxin testing of finished product and/or raw materials, • Perform technical review of test results for completeness and compliance to cGMP to ensure that documentation, controls and traceability are in place to maintain integrity, • Prepare and review preparation of media, reagents, test samples and equipment as required, • Prepare microorganisms for identification, • Understand and demonstrate aseptic technique, • Maintain laboratory cleanliness and inventory of microbiology supplies, • Familiar with GxP (Good Manufacturing Practice, Good Laboratory Practice and Good Documentation Practice), • Assist with environmental monitoring and microbiological trend reports Required Education and Experience • B.S. degree in Microbiology, Biology or related scientific field, • Minimum 1 year of experience in a microbiology laboratory or pharmaceutical industry, • Knowledge of good analytical and laboratory techniques, GxP, USP and FDA requirements, • Knowledge in statistical data analysis and its application to pharmaceutical or compounding processes and quality controls, • Must exhibit good analytical, writing (GDP), interpersonal and organizational skills, • Must be able to meet deadlines, • Must be detail oriented and have multi-tasking capabilities with ability to prioritize, • Must exhibit strong computer skills including but not limited to software packages supporting statistical data analysis, word processing, and project management programs, • Must have the ability to work in a fast-paced environment, • Must exhibit excellent problem resolution skills, • Must be able to work independently and as part of a team, • Must exhibit punctuality and low absenteeism, • Must be able to sit, stand, reach and walk for prolonged periods of time Eligibility Qualifications • Must develop knowledge of 21 CFR Part 210 and 211 for cGMP operations, • Must be capable of wearing all protective gear (gown, hair bonnet, mask, beard cover, gloves, goggles) and maintain good personal hygiene (makeup, jewelry and other cosmetics are prohibited from the production areas), • May be necessary to work extended hours as needed, • May require weekend work Competencies • Communication Proficiency, • Time Management, • Organizational Skills, • Problem Solving/Analysis, • Quality, • Results Driven, • Technical Capacity, • Thoroughness Supervisory Responsibility This position has no supervisory responsibilities. Work Environment This job operates primarily in a controlled laboratory environment. This position requires the use of standard office equipment, and frequent standing and walking. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. • Able to sit and/or stand 8-10 hours or more per day as needed, • May sit, stand, stoop, bend and walk intermittently during the day; may be necessary to work extended hours as needed, • Finger dexterity to operate office equipment required, • Ability to lift up to twenty (20) pounds on occasion Position Type and Expected Hours of Work This is a full-time Mon-Fri 7AM-3:30PM position. Because of the nature of the business, work schedules may vary at times. Travel No travel is expected for this position. Disclaimer The above job description is intended to describe the general nature and level of work being performed by employees assigned to this job. It is not designed to capture or illustrate a comprehensive list of all responsibilities, duties, and skills required of employees assigned to this job. AAP/EEO Statement Stokes Healthcare is an Equal Employment Opportunity and Affirmative Action Employer. Monday - Friday 7AM to 3:30PM