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.
Summary/Objective
The Microbiology Analyst II 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.
MUST - be able to work in Mount Laurel, NJ on-site.
Salary Starting at $25.00 hourly based on experience plus 2 bonuses a year.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
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Assist in method validation for sterility, bioburden, endotoxin, particle size distribution of products including, but not limited to, injections, ophthalmic preparations, oral tablets, oral liquids, raw materials, and components
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Assist in method development and validation for rapid sterility and bioburden test methods, specifically using ATP bioluminescence detection
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Assist in method development and validation for Antimicrobial Effectiveness Testing (AET) for sterile and non-sterile finished product
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Prepare and review final validation summary reports for clients
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Perform and/or assist in investigations
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Perform routine analysis of finished product, raw material, and components according to established specifications and procedures relating to:
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Sterility
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Bioburden
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Endotoxin
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AET
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Particulate Matter
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Container Closure
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Particle Size Distribution
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Water Activity
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Perform atypical particulate inspection and prepare report
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Performs media qualification (Sterility and Growth promotion)
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Support microbiological testing on facility water (WFI, CS, etc.) and biological indicators
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Record and review data following GDP
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Support writing and review of protocol, standard operating procedure and work instructions
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Performs technical review of test results for completeness and compliance to GDP to ensure that documentation, controls and traceability are in place to maintain integrity
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Prepares and reviews in-house media, reagents, and test samples as required
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Prepare microorganisms for identification, perform Gram staining. Perform and interpret microbial identification results
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Performs sample receipt, manages and disposes analyzed samples as needed
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Perform and maintain laboratory and equipment cleanliness
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Perform and maintain inventory of microbiology supplies and lab stocking
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Perform and assist with microbiological trend reports as required
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Must be proficient in training new and existing employees
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Assist in regulatory audits
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Understand and demonstrate aseptic technique
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Proficient in membrane filtration in relation to sterility and bioburden testing
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Familiar with GxP (Good Manufacturing Practice, Good Laboratory Practice and Good Documentation Practice)
Required Education and Experience
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B.S. degree in Microbiology, Biology or related scientific field
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Minimum 3 years of experience in a microbiology laboratory or pharmaceutical industry
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Knowledge of good analytical and laboratory techniques, GxP, USP and FDA requirements
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Knowledge in statistical data analysis and its application to pharmaceutical or compounding processes and quality controls
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Must exhibit good analytical, writing (GDP), interpersonal and organizational skills
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Must be able to meet deadlines
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Must be detail oriented and have multi-tasking capabilities with ability to prioritize
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Must exhibit strong computer skills including but not limited to software packages supporting statistical data analysis, word processing, and project management programs
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Must have the ability to work in a fast-paced environment
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Must exhibit excellent problem resolution skills
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Must be able to work independently and as part of a team
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Must exhibit punctuality and low absenteeism
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Must be able to sit, stand, reach and walk for prolonged periods of time
Eligibility Qualifications
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Must develop knowledge of 21 CFR Part 210 and 211 for cGMP operations
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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)
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May be necessary to work extended hours as needed.
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May be require weekend work.
Competencies
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Communication Proficiency
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Time Management
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Organizational Skills
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Problem Solving/Analysis
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Quality
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Results Driven
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Technical Capacity
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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.
Language Skills
Must be able to read, write, speak and understand English fluently and have the ability to read and interpret documents such as operating and maintenance instructions and procedure manuals.
Mathematical Skills
Uses addition, subtraction, multiplication and the division of numbers including decimals and fractions when checking of reports, forms, records and comparable data where interpretation is required involving basic skills knowledge.
Reasoning Ability
Must have the ability to solve practical problems and deal with a variety of concrete variables in situations where substantial standardization exists. Must be able to interpret instructions furnished in written, oral, and diagram or schedule form.
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.
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Able to sit and/or stand 8-10 hours or more per day as needed
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May sit, stand, stoop, bend and walk intermittently during the day; may be necessary to work extended hours as needed
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Finger dexterity to operate office equipment required
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Ability to lift up to twenty (20) pounds on occasion
Position Type and Expected Hours of Work
This is a full-time 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.
