Quality Assurance Analyst

Job Description

Job Description

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.

Job Title

Quality Assurance Analyst

FLSA Status

Non-exempt

Salary

Starting at $20/hour based on experience plus twice a year bonuses

Job Summary

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

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• 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

Required Education and Experience

• 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

Competencies

• Communication Proficiency
• Problem Solving/Analysis
• Quality
• Results Driven
• Technical Capacity
• Thoroughness

Supervisory Responsibility

This position has no supervisory responsibilities.

Work Environment

This job operates primarily in an office 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, stand, squat, kneel, reach and walk for prolonged periods of time
• May need to lift up to twenty-five (25) 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.