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Form of work
SalaryWhy Stokes?
Stokes Healthcare is a privately-owned business comprised of two divisions: Epicur Pharma (503B facility) and Stokes Pharmacy (503A pharmacy). The two 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.
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. 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. Because patients’ lives depend on it. To produce the highest quality compounded drugs, the FDA highly recommended compounding pharmacies obtain registration by the FDA as an outsourcing facility. Only a handful of compounding pharmacies in the entire nation did so. Epicur Pharma has the expertise and dedication to meet these high standards for consistency and quality—one more reason that patients and doctors have trusted Stokes Healthcare for their medication needs for more than 40 years.
Adding a unique new offering to the veterinary industry, Epicur Pharma is a mini-manufacturer, producing drugs such as Tacrolimus Eyedrops, Buprenorphine Injection and Gabapentin tablets. Epicur is overseen by the FDA and is considered a 503B Registered Outsourcing Facility. Epicur follows Current Good Manufacturing Practices (cGMP) which are the same rules and regulations as the pharmaceutical companies. 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 will be distributed directly to veterinary hospitals from our outsourcing facility and offered through Stokes Pharmacy for individual patient prescriptions.
At Stokes, we offer competitive salaries and a comprehensive benefits package that includes medical, dental and vision coverage, Health Reimbursement Account, Flexible Spending Account, 401(K) retirement savings plan with a generous employer match, paid holidays and vacation time, and an excellent working environment. We are conveniently located in Mount Laurel, New Jersey, just minutes from Philadelphia and the New Jersey 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.
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 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.
