QC Analyst

Job#: 2021242

Job Description

Apex Systems is seeking a QC Analyst near Winchester, KY for a contract to hire opportunity with a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service.

This role is responsible for Environmental Monitoring sampling, analyzing, and aseptic monitoring and microbiological testing to support Phase I/II GMP manufacturing. The QC Analyst works in a fast-paced environmental supporting the quality control department of a CMO for manufacturing of biologic bulk drug substance, sterile finished drug product, and fill/finish.

Responsibilities

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 Works closely with Manufacturing and Quality Assurance staff to resolve quality issues with regard to the facility Effectively communicates results of own work through discussions and documentation with some input from supervisor Flexibility in following unique campaign requirements that may include off-hour and weekend work May conduct bioburden and membrane filtration testing on cleaning, in-process and release samples.

Experience & Education

Associates degree in a Life Sciences discipline and 2 years of relevant experience working in cGMP cleanrooms Experience working in cGMP Quality Control Experience with Microsoft Excel and Microsoft Word Strong attention to detail Familiarity with Good Manufacturing Practices (cGMPs) Have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks Must be able to work off hours or weekends as required LIMS or MODA experience a plus Experience conducting bioburden and membrane filtration testing a plus

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178 .

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.

4400 Cox Road

Suite 200

Glen Allen, Virginia 23060

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] (Do not submit resumes or solicit consultants to this email address). UnitedHealthcare creates and publishes the Transparency in Coverage Machine-Readable Files on behalf of Apex Systems.