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Quality Assurance Specialist

3 months ago

Mount Laurel, United States Epicur Pharma Full time

**Why 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 NJ shore.

**Job Title**

Quality Assurance Specialist

**FLSA Status**

Exempt

**Job Summary**

The Quality Assurance Specialist works directly with the Quality Assurance Manager and supports and assesses operational needs and activities to successfully achieve quality goals and metrics across multiple quality functions.

**Essential Duties and Responsibilities** include the following. Other duties may be assigned.
- Assist in the maintenance and tracking of all Quality related documentation including, but not limited to: SOPs, Protocols, NOEs, Investigations, CAPAs, Planned Deviations, Change Controls, etc.
- Maintains all investigation and CAPA related documentation as assigned while ensuring adherence to, and compliance with, established company quality policies, practices, SOPs and cGMPs.
- Assists in investigations, root cause analysis, Corrective and Preventive Action (CAPA) activities in accordance with the company’s Quality System.
- Tracks and trends appropriate metrics for open NOEs, Investigations, CAPAs, planned deviations, etc.
- Reports monthly metrics pertaining to NOEs, investigations, and CAPAs to Quality department management and other appropriate company personnel.
- Actively participate in the review and approval of batch record documentation to support quality release of drug product in a timely manner.
- Perform risk assessment to determine safety and efficacy of products.
- Assist in change control management program and document archival.
- Maintain compliance with company policies, regulatory requirements, quality specifications, safety standards, and sanitation practices.
- Perform routine audits of processes and establish gap analysis.
- Perform quality review of documentation and processes.
- Assists with SOP revision and participates in inspections, as needed.
- Assists in other areas of QA and may cross train across department, as needed.

**Required Education and Experience**
- Minimum of 6 years of experience in pharmaceutical manufacturing, quality assurance, and/or FDA regulated industry without degree.
- Minimum of 3 years of experience in pharmaceutical manufacturing, quality assurance, and/or FDA regulated industry, with degre