What are the responsibilities and job description for the GMP Quality Control Associate position at Acro Service Corp?
Job Title: Cleanroom Operations Manager
We are seeking a highly skilled and experienced Quality Assurance Specialist to join our team at Paragon Bioservices, a leading Biotech Contract Development and Manufacturing Organization (CDMO) located in Winchester, KY 40391. In this role, you will be responsible for ensuring the highest standards of quality and safety in our cleanrooms and laboratories.
About the Job:
As a member of our quality control department, you will be responsible for Environmental Monitoring sampling, analyzing, and aseptic monitoring and microbiological testing. You will work closely with manufacturing and QA staff to resolve quality issues and ensure compliance with Good Manufacturing Practices (cGMPs).
Responsibilities include but are not limited to:
Requirements:
The ideal candidate will have an Associates degree in a Life Sciences discipline and 2 years of relevant experience working in cGMP cleanrooms. Experience working in cGMP Quality Control, Microsoft Excel and Word, strong attention to detail, familiarity with Good Manufacturing Practices (cGMP's) and knowledge of basic scientific and regulatory principles used to solve operational, as well as routine quality tasks is required. LIMS or MODA experience and conducting bioburden and membrane filtration testing is a plus.
About Us:
At Paragon Bioservices, we are committed to delivering high-quality products and services to our customers and their patients. We offer a dynamic and supportive work environment, and opportunities for professional growth and development.
We are seeking a highly skilled and experienced Quality Assurance Specialist to join our team at Paragon Bioservices, a leading Biotech Contract Development and Manufacturing Organization (CDMO) located in Winchester, KY 40391. In this role, you will be responsible for ensuring the highest standards of quality and safety in our cleanrooms and laboratories.
About the Job:
As a member of our quality control department, you will be responsible for Environmental Monitoring sampling, analyzing, and aseptic monitoring and microbiological testing. You will work closely with manufacturing and QA staff to resolve quality issues and ensure compliance with Good Manufacturing Practices (cGMPs).
Responsibilities include but are not limited to:
- Primary responsibility is in Environmental Monitoring in classified cleanrooms.
- Monitoring of surfaces, air, and non-viable air quality of ISO 5, 7, and 8 cleanrooms.
- Conducts testing of utilities such as USP water, clean steam, and testing of other manufacturing environments (air, surfaces)
- Builds credibility within the lab group by performing high-quality work.
- Works closely with manufacturing and QA to coordinate routine EM, changeover EM, and monitoring to support client campaigns.
- Performs media fills and fill/finish monitoring which includes continuous monitoring of air quality, personnel aseptic technique, and environment integrity.
- Acts as Quality Control authority for aseptic flow and behavior within cleanrooms.
- Utilizes MODA to enter, compile, and trend environmental data for reporting purposes.
Requirements:
The ideal candidate will have an Associates degree in a Life Sciences discipline and 2 years of relevant experience working in cGMP cleanrooms. Experience working in cGMP Quality Control, Microsoft Excel and Word, strong attention to detail, familiarity with Good Manufacturing Practices (cGMP's) and knowledge of basic scientific and regulatory principles used to solve operational, as well as routine quality tasks is required. LIMS or MODA experience and conducting bioburden and membrane filtration testing is a plus.
About Us:
At Paragon Bioservices, we are committed to delivering high-quality products and services to our customers and their patients. We offer a dynamic and supportive work environment, and opportunities for professional growth and development.
