QA Operations Associate I

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

· 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.

JOB REQUIREMENTS:

· 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.

PHYSICAL DEMANDS:

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 ENVIRONMENT:

Work will occur in the following environments: office, laboratory, environmentally controlled production suites (ISO 7 & 8), and warehouse.