Quality Assurance Manager

POSTED: March 11, 2019
BUSINESS: Purdue GMP Center
POSITION TYPE: Full-time
START DATE: Immediate Availability

Essential Functions:

  • Perform all assigned duties according to established Quality Standards and policy, Procedures, and Work instructions.
  • Function as an advocate and ambassador for quality in all tasks and assignments.
  • Organize and lead assigned staff for carrying out assigned duties and responsibilities.
  • Ensure Quality systems are compliant with site procedures and industry standards including but not limited to Annual Product Reviews, complaints, CAPAs, and investigations.
  • Responsible to oversee and/or administer Quality Management Systems (i.e., Change Control, Document Control, CAPA, Product Complaints, Deviations, OOS, Annual Product Quality Reviews) as assigned
  • Demonstrate technical proficiency in analytical methodology and ensure quality control activities are carried out according to and with adherence to regulatory and internal requirements, cGMP and ICH compliance
  • Create, revise, review, and approve GMP documents such as SOPs, change controls, deviations, OOS, CAPAs, master and executed batch records, validation and qualification protocols and reports, testing and release of GMP starting materials, intermediates, APIs, and Drug Products to ensure compliance
  • Coordinate the investigation and closure of deviations and OOS with specific emphasis on comprehensive root cause analysis
  • Release batches of Finished product for market distribution
  • Participate and contribute to Quality Council.  Chair meetings in absence of QA Director.
  • Ensure appropriate CAPAs are initiated, implemented and monitored
  • Facilitate the Annual Product Review process
  • Supports ongoing quality system continuous improvement programs and initiatives, including risk management
  • Work with the quality control management team to continuously improve the quality, compliance and efficiency of QC operations
  • Serve as QA lead on analytical project teams and product operational teams
  • Function as a Quality department liaison to other departments including but not limited to Quality Control, Manufacturing Operations, and Supplier quality

Additional Responsibilities:

  • Effectively communicate to management any internal issues related to performance, processes, and procedures
  • Participate in and/or lead internal and external audits
  • Participate in FDA Inspections as required
  • Be a self-starting problem solver who drives risk-based results with awareness of both compliance and business considerations and a positive work style
  • Other duties as assigned

Knowledge/Skills/Abilities:

  • Working knowledge of FDA cGMP regulations, ICH and FDA Guidance for Industry, Compendial requirements, foreign regulations and standards
  • Working knowledge of QC Laboratory Operations and common laboratory instrumentation is required
  • Exemplary oral and written communications skills
  • Exemplary project management and organizational skills
  • Strong analytical and investigative skills
  • The ability to work independently with minimal supervision, interact with staff (at all levels) in a fast-paced environment, sometimes under pressure, remaining flexible, proactive, resourceful and efficient, with a high level of professionalism
  • Proficiency in Microsoft Word and Excel
  • Prior supervisory/management experience preferred
  • Strong organizational skills, with the ability to handle multiple tasks in a fast-paced environment
  • Experience interacting with FDA and other regulatory agencies

Education/Experience:

  • Bachelor’s Degree in a science or related field, such as Chemistry, Pharmacy, or Biology
  • 5 – 10 years with at least 5 years’ experience required in a quality related role within the pharmaceutical or medical device industry.  Previous experience within biotech or pharmaceutical QC position(s), particularly in a GMP environment, considered a plus.

Application Instructions:

Interested candidates please send your cover letter and resume to careers@gmpcenter.com

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