Oklahoma City, Oklahoma, United States · On-site
GENERAL SUMMARY: QA Operations Associate I is responsible for maintaining quality oversight of operational areas by working closely with Operation’s personnel and performing various checks during manufacturing proc…
Skills: cGMP, Good Documentation Practices, Quality Assurance, Process Auditing, CAPA
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Maintains quality oversight of operational areas to ensure compliance with cGMP and company procedures. Performs process audits, reviews batch records, and manages quality system requirements including CAPA and deviation reports.
Requires a Bachelor's degree in science or life sciences, or equivalent experience. Candidates should have 0 to 2 years of Quality Systems experience, preferably within an FDA regulated manufacturing facility.
GENERAL SUMMARY:
QA Operations Associate I is responsible for maintaining quality oversight of operational areas by working closely with Operation’s personnel and performing various checks during manufacturing processes to ensure that current Good Manufacturing Practices (cGMP’s) are followed. The QA Operations Associate I also assesses regulatory and quality risks in activities and processes according to GMP and Cytovance Standard Operating Procedures.
· Ensures compliance with GMP’s and company-specific procedures.
· Reviews records to ensure they are complete, accurate and compliant with GMP and Good Documentation (GDP) requirements. Records include, but are not limited to, batch records, Quality Control reports, equipment calibrations and logbooks.
· Reports errors, deficiencies, discrepancies and observations to management.
· Performs Quality functions in classified areas, which include but are not limited to, process audits, room releases, documentation review, acceptance sampling, product and sample collection, and inventory control and retain inspections.
· Interface with functional groups, such as Manufacturing, Quality Control, Program Management, and Shipping, to determine events (errors, deficiencies, discrepancies, deviations and other observations) and report to management. May stop operations when product safety is or may be compromised.
· Support the CAPA System and Quality System requirements, to include initiating, authoring, reviewing, and approving (upon completed training requirements): Planned and Unplanned Deviation Reports (DEV), Nonconforming Material Reports (NONC), and Corrective/Preventive Actions (CAPA) for assessment and resolution of events.
· Apply quality compliance theories and principles to independently address a variety of issues of moderate scope.
· Interface with client QA as directed by QAOps Client Manager, providing notification of events impacting client product and materials.
· Provide guidance on controlled documents (content, quality, and document lifecycle), identifying gaps, addressing documentation needs, and suggesting process improvements.
· Perform and analyze event trending to identify areas for improvement.
· Initiate and participate in standard operating procedure (SOP) and master batch record (MBR) revisions to improve compliance.
· Willing to work flexible hours to support organizational needs.
· Bachelor’s Degree with emphasis on science / life sciences or commensurate experience.
· 0 to 2 years relevant Quality Systems experience, preferably working within an FDA regulated manufacturing facility. 5 + years required if college degree is substituted with experience.
· Ability to read, analyze, and interpret common scientific and technical information in English.
· Ability to respond to common inquiries or complaints from internal and external customers and regulatory agencies.
· Ability to define problems, collect data, establish facts, and draw valid conclusions.
· Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
· Ability to operate Microsoft Office software: Excel, Word, Outlook, and PowerPoint.
While performing the duties of this job, the employee is frequently required to walk, stand, sit, talk, and hear. The employee is occasionally required to use hands to finger, handle, or feel; reach with hands and arms; climb or balance; and stoop, kneel, crouch, or crawl.
Work will occur in the following environments: office, laboratory, environmentally controlled production suites (ISO 7 & 8), and warehouse.
We are your responsive, reliable, and resourceful CDMO Partner.
Streamline your biomanufacturing programs with Cytovance Biologics! Born from a decades-long history in drug development, we believe in creating a healthier world where every biologic’s path to commercialization is advanced by a CDMO partner that delivers ingenuity end-to-end. Whether your large molecule product needs the flexibility of a customized approach or the efficiency of a predetermined platform process, Team Cytovance has the deep expertise in microbial and mammalian expression systems to support your scale-up at every stage. From early needs like cell line development and strain selection to cGMP manufacturing for clinical and commercial production, our team is your team. Together, we will guide your asset through the complexities of manufacturing and deliver it to its next milestone. With a >97% batch success rate and quality, scalability, and reproducibility top of mind, we bring a range of therapeutic proteins and antibodies to the clinic, including: ● Biosimilars ● Cytokines ● Enzymes/Hormones ● Fusion Proteins ● Bispecific, Fragment, and Monoclonal Antibodies ● Recombinant Protein ● Vaccines ● And More
Offices: 800 Research Pkwy, Oklahoma City, OK 73104, US
We are your responsive, reliable, and resourceful CDMO Partner.
Streamline your biomanufacturing programs with Cytovance Biologics! Born from a decades-long history in drug development, we believe in creating a healthier world where every biologic’s path to commercialization is advanced by a CDMO partner that delivers ingenuity end-to-end. Whether your large molecule product needs the flexibility of a customized approach or the efficiency of a predetermined platform process, Team Cytovance has the deep expertise in microbial and mammalian expression systems to support your scale-up at every stage. From early needs like cell line development and strain selection to cGMP manufacturing for clinical and commercial production, our team is your team. Together, we will guide your asset through the complexities of manufacturing and deliver it to its next milestone. With a >97% batch success rate and quality, scalability, and reproducibility top of mind, we bring a range of therapeutic proteins and antibodies to the clinic, including: ● Biosimilars ● Cytokines ● Enzymes/Hormones ● Fusion Proteins ● Bispecific, Fragment, and Monoclonal Antibodies ● Recombinant Protein ● Vaccines ● And More
Offices: 800 Research Pkwy, Oklahoma City, OK 73104, US
