Quality Assurance Manager

Job DescriptionJob Description

Why Stokes?

Stokes Healthcare is a privately-owned business comprised of three divisions: Epicur Pharma (503B facility), Stokes Pharmacy (503A pharmacy) and STEP Labs Testing Facility. The 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, paid time off (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 Manager

FLSA Status

Exempt

Salary

Starting at $80,000 based on experience plus twice a year bonuses

Job Summary

The Quality Assurance Manager will oversee operations at STEP Labs Testing Facility. This includes, but is not limited to, managing quality systems, quality procedures relating to raw materials and products, method validations, managing day-to-day Quality Assurance operations, and the release of test reports within an analytical environment. This position leads the ongoing process focused on assessing, evaluating, and improving all aspects of quality management to enhance performance and maintain data reliability. The Quality Assurance Manager reports directly to the Laboratory Director/Managing Director.

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

• Ensure compliance with FDA regulatory guidance, ISO 17025, and company policies
• Lead regulatory inspections and audits by FDA, applicable regulatory bodies, and accreditation bodies
• Develop Quality Assurance procedures to maintain compliance and enhance reliability of laboratory procedures
• Monitoring applicable regulatory requirements for updates
• Perform investigations for deviations, discrepancies, and out-of-specifications
• Lead investigations for deviations/discrepancies for laboratory departments
  • Perform root cause analysis using industry standards, such as FMEA, 5Whys and Fishbone diagrams
• Perform trend analysis of critical process parameters and evaluate KPIs to determine procedure effectiveness
• Assist in the development and execution of relevant corrective and preventative action
• Oversee training program to ensure staff is adequately trained and perform competency assessments as needed
• Ensure that the company policy for data integrity and ALOCA+ principles are met in the laboratory
• Oversee equipment and instrumentation calibration, validation, and maintenance program
• Periodic review of data to comply with Laboratory Procedures, Test Method, Protocols, GxP, and work with personnel for any correction and promote a CGMP cultureLead in the development and implementation of new and existing processes:
  • Quality Management System
  • Sample Coordination
  • Laboratory Information Management System
  • Environmental Monitoring System
• Oversee the review and approval of testing documentation to support quality release of test reports in a timely manner
• Able to multitask, to work with dynamic changes of plans, to communicate with cross functional teams, complete the work within the timelines
• Oversee change control management program and documentation archival
• Work closely with Quality Control to evaluate all customer issues, perform root cause analysis and respond appropriately
• Lead in development and maintaining of quality inspection process for analytical and microbiology testing
• Oversee performance of routine audits of processes and perform gap analysis
• Monitor controlled substance chain of custody transfers throughout laboratory operations
• Support Environmental, Health & Safety, and Logistic Teams

Required Education and Experience

• Minimum of 8 years of experience in analytical testing, microbiology testing, or pharmaceutical manufacturing, or applicable field, without a degree
• Minimum of 6 years of experience analytical testing, microbiology testing, or pharmaceutical manufacturing, or applicable field, with degree
• 3+ years’ experience in a supervisory role,
• Bachelor’s Degree in Biological Science, Chemistry, Biomedical Engineering, or relevant field,
• Excellent communication and technical writing abilities
• Extensive knowledge with GxP, FDA, ICH, ISO, USP, PDA, DEA, and OSHA requirements
• Proficient with Microsoft Office applications (Word, Excel, etc.)
• Must be capable of wearing all protective wear as required. This includes, but not limited to, mask, gloves, gown, hairnet, safety goggles, etc.
• Must have strong organizational skills and exceptional attention to detail
• Must exhibit punctuality and low absenteeism
• Able to work independently and as part of a team
• 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

Competencies

• Communication Proficiency
• Problem Solving/Analysis
• Quality Oriented
• Results Driven
• Technical Capacity
• Thoroughness
• Troubleshooting
• Time Management
• Employee Engagement
• Work Independently

Supervisory Responsibility

This position has supervisory responsibilities of the Quality Assurance Department.

Work Environment

This job operates primarily in the Quality and Manufacturing Areas. This position requires the use of standard office equipment, and frequent standing and walking.

Skills

Must be able to read, write, speak and understand English fluently and have the ability to read and interpret documents such as operating and maintenance instructions and procedure manuals.

Mathematical Skills

Uses addition, subtraction, multiplication and the division of numbers including decimals and fractions when checking reports, forms, records and comparable data where interpretation is required involving basic skills knowledge.

Reasoning Ability

Must have the ability to solve practical problems and deal with a variety of concrete variables in situations where substantial standardization exists. Must be able to interpret instructions furnished in written, oral, and diagram or schedule form.

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 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.