What are the responsibilities and job description for the Quality Control Analyst I – Manufacturing position at Stokes Pharmacy?
Why Stokes?
Stokes Healthcare is a privately-owned business comprised of two divisions: Stokes Pharmacy (503A pharmacy) and Epicur Pharma (503B facility). 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.
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.
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
Quality Control Analyst I – Manufacturing
FLSA Status
Non-exempt
Job Summary
Quality Control Analysts are responsible for ensuring the quality of materials and that finished drug products are manufactured to meet current Good Manufacturing Practice (cGMP) and Epicur Pharma standards.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Perform quality inspection on incoming materials intended to be used in the manufacturing of drug products.
- Perform in-process quality checks and inspections for finished drug products to ensure standards are met.
- Assist in documenting and maintaining material and product samples (i.e. retains, stability, finished products, etc.)
- Perform logbook reviews for accuracy and good documentation practice.
- Document inspection and testing results by completing QC reports and logs
- Participate in the execution/verification of corrective and preventative action (CAPA) and change controls.
- Complete batch record documentation for quality release of finished product.
Required Education and Experience
- High school diploma or general education degree (GED).
- Familiar with cGMP and 21 CFR Part 210 & 211 preferred, but not required.
- Must be capable of wearing all protective gear (gown, hair bonnet, mask, beard cover, gloves, goggles).
- Must be able to follow gowning/garbing procedures (cannot wear makeup, must remove jewelry before entering manufacturing area).
- Must possess strong verbal, written, and oral communication skills.
- Must be able to work independently and with a team.
- Able to recognize priorities and take action; make productive use of time.
- Must exhibit punctuality and low absenteeism.
- Able to sit and/or stand 8-10 hours or more per day as needed.
- May need to lift up to twenty-five (25) pounds on occasion.
Competencies
- Communication
- Organizational Skills
- Results Driven
- Technical Capacity
- Thoroughness
Supervisory Responsibility
This position has no supervisory responsibilities.
Work Environment
This job operates primarily in a controlled manufacturing environment. This position requires the use of standard office equipment and frequent standing/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.
- May need to lift up to twenty-five (25) pounds on occasion
- This position is moderately active and requires standing and walking for a majority of the shift.
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.
