Quality Control Analyst - Environmental Monitoring - mid shift

Stokes Pharmacy•Mount Laurel Township, NJ

2d•Onsite

About The Position

This position requires an individual who can work collaboratively with production personnel to optimize quality aspects of operations. The role involves working in a controlled laboratory environment and requires the use of standard office equipment, along with frequent standing and walking. The company, Stokes Healthcare, is a privately-owned business with three divisions: Stokes Pharmacy, Epicur Pharma, and STEP Labs. They have built a reputation for unwavering quality and superb service by combining traditional craftsmanship with advanced knowledge and technologies, prioritizing safety and quality because patients' lives depend on it.

Requirements

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

Responsibilities

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