QA Associate in Lexington, KY at Apex Life Sciences

Date Posted: 10/2/2018

Job Snapshot

Job Description


Quality Assurance Associate

POSITION SUMMARY

The Quality Assurance Associate will be responsible for the documented assurance that all functional groups are in compliance with current Good Manufacturing Practices (cGMPs) as described in the various regulations and standards defined by the clients Quality Manual.  

PRIMARY RESPONSIBILITIES

  • Review and approve controlled documents requiring Quality Assurance approval signatures including, but not limited to: Nonconforming Material Reports, Calibration Records, Material Specifications, and Qualification Protocols.
  • Perform on-the-floor review of production documentation, including batch production records and supporting documentation, and provide GMP support (as appropriate) to production activities.
  • Must be able to independently perform the following functions: line clearances, disposition controlled materials and components, approve shipping requests, manage reserve program, and perform product inspections.
  • Assist in compliant event report investigations being conducted, resolved, and closed in a timely manner.
  • Assist in Quality Management Reviews and Annual Product Reviews, as appropriate.
  • Assist ongoing quality improvement processes with interdepartmental teams.
  • Assist in the development and review of departmental and other functional departments’ Standard Operating Procedures (SOPs), work instructions, etc.
  • Provide support for executed batch record and process simulation record review.
  • May assist the Quality Unit in regulatory activities that support product filings.
  • Assist with internal audits of clients systems and departments.
  • May participate in client and clients project meetings.
  • Provide support during customer and / or regulatory inspections and for responses associated with audit observations, as required.
  • May cross-train and provide support for other Quality Unit (Analytical Quality Control, Microbiology Quality Control, Document Systems, and Validation) as appropriate.
  • Other duties as required by organizational demands.

QUALIFICATIONS

  • Preferred to have a minimum of a B.A. or B.S. in scientific field and/or equivalent degree.
  • Minimum of 2 years progressive experience in a related regulated industry is required.     
  • Must have good computer skills.

WORK ENVIRONMENT

  • Ability to work in a high demand office and manufacturing setting with extended time with “on the floor” activities (in the lab, manufacturing core, and warehouse settings).
  • Position will require extended hour shift work and may include evenings and weekends.
  • Ability to work in a safe manner with materials of potential high potency and/or toxicity in a limited capacity.
  • Ability to cross-train in identified Quality Unit activities outside of the QA department in a supporting capacity.
  • Some physical movement (lifting, manipulation of materials and equipment, bending, standing, etc.) may be required.

DEVELOPMENT PLAN

  • It is required that this position attend industry conferences to stay informed of current industry trends and expectations.
  • Must continually seek industry recognized certifications (e.g. CQA, CPGP, or RAPS).

Contact: Ali Miller // ammiller@apexlifesciences.com // 513-605-5495

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, 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 844-463-6178.




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