Quality System Specialist


York, PA


Quality System Specialist

Job Summary:

Manages & performs quality systems functions.


  • Independently prioritizes work load based on input from other functions, customer needs and business requirements.
  • Comprehensively, accurately and independently conducts final review of all batch records, line clearances, supporting data and testing requirements assuring compliance with documented procedures, federal regulations and customer requirements. Issues and assigns deviations where appropriate; audits and facilitates timely resolution thereof.
  • Facilitates product release and generation of certificates of compliance and analysis upon successful completion of batch record review and QC testing.
  • Serve as liaison with customer and internal departments; ensuring that day-to-day goals are met, as well as coordinating timely release of product. Provide product release and any other documentation to customer as required. Coordinates shipping of certified material with Customer Services, Operations, and customers.
  • Coordinates the generation, review, revision, approvals & training of all quality system procedures and related documentation including but not limited to MSOPs, QSOPs, LSOPs, ACALs, Forms, PATM/ATM, Raw Material Specifications, Master Batch Records, change controls, preventive actions, validation protocols, etc.; creates and maintains electronic indexes thereof.
  • Receives purchase order information from Customer Service, generates batch record numbers for batch record generation.
  • Schedules, organizes and participates in internal and/or external audits (e.g. client, FDA, DEA, etc.).
  • Processes and maintains of validation protocols.
  • Helps with management of Preventative Actions, Deviations, Laboratory Investigation Reports and Change Controls in a backup function.
  • Identifies and implements Continuous Improvement Initiatives
  • Completes required paperwork/ documentation accurately and neatly.
  • Notifies appropriate associates when documents are updated and released; ensures functional and divisional compliance with training requirements.
  • Identifies & implements opportunities for improvement in system effectiveness and productivity.
  • Initiates protocols when necessary.
  • May assist in the investigation of non-conformances and/or customer complaints.
  • Comply with all Corporate Safety policies.
  • Perform other duties and responsibilities as assigned.


  • Requires bachelors degree in technical or engineering discipline and/or a minimum of 5 years of quality experience in Quality Systems; working knowledge of cGMP and GLPs.
  • Ability to perform required duties independently, efficiently and effectively with minimal supervision.
  • Able to use initiative in carrying out assignments independently without specific instructions; exercises sound judgment and discretion regarding when to request guidance and/or assistance from others.
  • Ability to thoroughly review documents for accuracy and completeness.
  • Ability to read and interpret documents such as test methods and procedure manuals.
  • Ability to work with mathematical concepts such as averages, standard deviation and other basic statistical functions.

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