What are the responsibilities and job description for the Cleanroom Operations Manager position at Acro Service Corp?
Job Title: Quality Assurance Specialist
Are you passionate about quality and safety? Do you want to make a difference in the lives of patients? Join our team at Paragon Bioservices, a leading Biotech Contract Development and Manufacturing Organization (CDMO) located in Winchester, KY 40391. As a GMP Quality Control Associate, you will play a key role in ensuring the highest standards of quality and safety in our cleanrooms and laboratories.
About the Job:
In this role, you will be working closely with our quality control department to conduct Environmental Monitoring sampling, analyzing, and aseptic monitoring and microbiological testing. You will also be responsible for maintaining accurate records and reports, and communicating results to the team.
Key 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.
Are you passionate about quality and safety? Do you want to make a difference in the lives of patients? Join our team at Paragon Bioservices, a leading Biotech Contract Development and Manufacturing Organization (CDMO) located in Winchester, KY 40391. As a GMP Quality Control Associate, you will play a key role in ensuring the highest standards of quality and safety in our cleanrooms and laboratories.
About the Job:
In this role, you will be working closely with our quality control department to conduct Environmental Monitoring sampling, analyzing, and aseptic monitoring and microbiological testing. You will also be responsible for maintaining accurate records and reports, and communicating results to the team.
Key Responsibilities include but are not limited to:
- 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)
- Utilizes MODA to enter, compile, and trend environmental data for reporting purposes.
- Acts as Quality Control authority for aseptic flow and behavior within cleanrooms.
- Works closely with manufacturing and QA to coordinate routine EM, changeover EM, and monitoring to support client campaigns.
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.
