Quality Assurance Analyst

Stokes Pharmacy•Mount Laurel Township, NJ

7h•Onsite

About The Position

The Quality Assurance Analyst is responsible for ensuring cGMP standards are maintained to ensure process and product quality. 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.

Requirements

Bachelor’s Degree in Biological Science, Chemistry, Biomedical Engineering, or relevant field
1 years of experience in pharmaceutical/cosmetic manufacturing environment or relevant field, is preferred
Prior experience in Quality Assurance preferred
Familiar with GxP, FDA, ICH, OSHA requirements, is preferred
Experience using Minitab, Excel, and/or relevant applications
Must have knowledge of basic principles, theories and laws, policies and procedures that pertain to compounding
Must be capable of wearing all protective wear as required. This includes, but not limited to; mask, gloves, gown, hairnet, safety goggles etc.
Must be able to work with chemicals used in the preparation of compounds following any special safety precautions as required.
Must have strong organizational skills and exceptional attention to detail
Must exhibit punctuality and low absenteeism
Able to work independently, as well as part of a team

Responsibilities

Assist in maintaining Master Batch Record documentation (i.e. new, revision, obsolete, etc.)
Review Production Batch Record documentation for product release
Assist in the completion of investigation
Assist in the implementation of new and revised policies/procedures
Assist in change control management
Maintain compliance with company policies, regulatory requirements, quality specifications, safety standards, and sanitation practices
Perform routine audits of processes and gap analysis relating to production operations
Perform quality review of documentation and processes
Ensure cGMP standards are maintained and coordinate efforts to build