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Principal Quality Engineer in St. Louis, MO at Apex Life Sciences

Date Posted: 12/12/2018

Job Snapshot

Job Description


Principal Quality Associate (Engineer)

Summary:

  • Our client is looking for an experienced QA professional that provides leadership and experience with introduction of new client molecular entities, for a large pharmaceutical company in the Greater St. Louis, MO area. This is a non-supervisory role, reporting to the Senior Director of Quality, which is a part of the Quality Unit. Please send resumes directly to Lauren Pritts lpritts@apexlifesciences.com to be considered. 

Responsibilities:

  • This individual performs client quality project management, assisting the client in Quality needs and understanding of Quality guidelines and Regulations, ensures commitments and adherence to Quality Agreements.
  • A Principal Quality Associate is a recognized subject matter expert in one or more of the following Quality Assurance areas: cGMP compliance, deviation management, or biopharmaceuticals manufacturing.
  • A Principal Quality Associate is responsible for, but not limited to, batch record review, deviation approval, change control approval and ensuring alignment of the assigned programs to the site quality requirements.
  • Personnel are responsible for adhering to GMP standards of job performance including ensuring that training is current in all aspects.
  • Personnel are expected to take the initiative to improve the quality of operations and to improve and maintain a quality culture with a goal of consistency.
  • Provide guidance and oversight on all aspects of quality to drive clinical and commercial programs towards successful outcomes.
  • Act as Liaison between the Client and sub-groups of Quality Assurance during technology transfer of new products
  • Ensure development of process adheres to applicable regulations based on phase appropriate FDA, EMA and ICH guidelines. Oversight to include work from early phase GMP manufacturing through Commercial.
  • Review/assist in the establishment and maintenance of Client Quality Agreements for assigned program(s).
  • Review and Approve GMP documents such as, but not limited to, Batch Records, Standard Operation Procedures, Process Validation Protocols/Reports, Deviations and Change Controls.
  • Contribute to continual process improvement by participating in meetings, seminars, and site projects
  • Tracking/Trending of program robustness through evaluation of CAPA's, Change Controls, Deviations, and other KPIs-
  • Participate in client facing meetings in support of program(s)
  • Good organizational skills and problem solving abilities.
  • Other duties as assigned.

Requirements:

Education

  • Bachelor’s degree in Biology, Biochemistry, Chemistry or other science related field.

Experience

  • 8+ years of experience in a regulated manufacturing environment
  • ASQ CQE or ASQ CQA required; ASQ CSSGB or higher desired

Equivalency

  • 5+ years of experience in a regulated manufacturing environment with direct quality experience may be considered


Knowledge, Skills, Abilities

  • Knowledgeable of FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals.
  • Ability to apply GMP regulations and other international guidelines to all aspects of the position.
  • Demonstrated ability to make key decisions
  • Technical Writing skills
  • Technical knowledge of biopharmaceutical manufacturing is desirable
  • Proficient in use of statistical analysis and methods
  • Microsoft Project/Project Management is desirable
  • Work attitude that exhibits drive, creativity, collaboration, assertiveness, good judgment, decision-making and ambition.
  • Excellent interpersonal skills
  • Ability to build and maintain relationships with internal and external customers
  • Highly functioning team leader and team member in a multi-skilled, dynamic business environment.
  • Proven ability to influence others and lead significant change.
  • Strong communication skills, both written and verbal
  • Ability to work on multiple projects simultaneously.
  • Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
  • Effective presentation skills.

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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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