Quality Control Analyst, EM

Epicur; Mount Laurel Township (NJ); On-site; USD 23,000 - 32,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Life insurance

401(k) with match

Bonus program

Paid holidays

Vacation time

Personal time

Job summary

Stokes Healthcare in Mount Laurel, NJ is seeking an individual to collaborate with production personnel to optimize quality aspects of operations. The role involves aseptic gowning, applying GxP, environmental monitoring, and documentation review to ensure regulatory compliance.

The position requires a Bachelor’s degree in biology/microbiology or 1 year of cGMP experience, ability to wear protective gear, and strong communication skills.

Qualifications

• Bachelor’s degree in biology, microbiology, or related field, or 1 year relevant cGMP experience.
• Able to wear all protective gear (gown, hair bonnet, mask, beard cover, gloves, goggles).
• Follow gowning/garbing procedures (no makeup, remove jewelry before sterile compounding).
• Learn 21 CFR Part 210 and Part 211, along with other cGMP regulations.
• Work with small, delicate machinery to complete dosage forms in a timely manner.
• Strong verbal, written, and oral communication skills.
• Able to work independently and with a team.
• Problem-solving skills.
• Punctuality and low absenteeism.
• Able to sit/stand 8-10 hours or more per day.

Responsibilities

• Learn aseptic gowning and technique in a cleanroom environment.
• Apply GxP (GMP, GDP, GLP) to operations.
• Perform environmental monitoring and read/review microbial samples.
• Assist in media-fill process validations and inspection of filled units.
• Review cleaning records, line clearance forms, and inventory/equipment checklists.
• Document non-compliance and escalate with supervisor/lead as needed.
• Review production batch records for cGMP compliance and report abnormalities.
• Audit aseptic technique and operation documentation.
• Ensure completeness and accuracy of all documents and records.
• Assist with closure of Change Controls.
• Assist with equipment calibration program and maintenance records.
• Identify and assess quality risks per regulatory guidelines.
• Assist in training of new employees and other technical personnel.

Skills

Communication

Teamwork

Regulatory compliance

Problem solving

Attention to detail

Education

Bachelor’s degree in biology, microbiology, or related field

1 year relevant experience in cGMP environment

Job description

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.

Summary/Objective

This position requires an individual who can work collaboratively with production personnel to optimize quality aspects of operations.

Schedule

Monday - Friday 7AM-3:30PM Full time

Starting at $20.00 hourly depending on experience plus twice yearly bonuses.

Essential Duties and Responsibilities

include the following. Other duties may be assigned.

• Learn aseptic gowning and technique within a cleanroom environment
• Learn and apply GxP (GMP, GDP, GLP) to operations
• Perform viable/non-viable environmental monitoring and read/review microbial samples
• Assist in the media-fill process validations and inspection of filled units
• Perform document review of operation activities such as cleaning record, line clearance forms, and inventory/equipment checklist
• Document non-compliance and work with supervisor/lead if further investigation is needed
• Review production batch records and associated data for product release; determine if records are within cGMP regulations; review data obtained for compliance specifications and report abnormalities
• Perform audits on aseptic technique and operation documentation
• Ensure completeness and accuracy of information contained in all documents, document files, databases, and documentation systems
• Ensure timely assessment and closure of Change Controls
• Assist with equipment calibration program and maintenance record files
• Identify and assess quality risk in activities and processes according to regulatory guidelines and Standard Operating Procedures
• Assist in the training of new employees and other technical personnel

Required Education and Experience

• Bachelor’s degree in biology, microbiology, or other related field, or 1 year relevant experience in cGMP environment
• 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 sterile compounding)
• Must learn and understand 21 CFR Part 210 and Part 211, along with other relevant cGMP regulations
• Must be capable of working with small, delicate pieces of machinery to complete appropriate dosage forms in a timely manner
• Must possess strong verbal, written, and oral communication skills
• Must be able to work independently and with a team
• Must possess problem-solving skills
• Ability 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
• Communication
• Organizational Skills
• Problem Solving/Analysis
• Results Driven
• Technical Capacity
• Thoroughness

Supervisory Responsibility

This position has no supervisory responsibilities.

Work Environment

This job operates primarily in a controlled laboratory environment. This position requires the use of standard office equipment, and frequent standing and walking.

Language 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 of 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.

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Physical Demands

• 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. (8-10 hours)

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 Aff…