Quality Assurance

  • location: Lexington, MA
  • type: Contract
  • salary: $37.99 - $44.69 per hour

job description

Quality Assurance

QA/QC Specialist III

Job Summary

The Quality Assurance Professional will work in the US External QA team of the client's Human Genetic Therapies Quality Assurance Department. This unit oversees contract manufacturing (3rd party manufacturing) operations, packaging & labeling operations (external and internal), internal warehouse operations, and logistics performed on behalf of Shire. This unit also provides QA support for Quality Control (drug product testing and stability) and Pharmaceutical Analytical Development (PAD) operations. This position provides support to the Quality Control unit including Commercial (Internal & External), Development QC Operations and Analytical Development.

Job Responsibilities

  • Responsibilities include support of Commercial QC Operations: Drug Product Exception Reporting OOS, Trending, Aberrant Results; Stability; Reference Standard & Critical Reagents; Method Validation & qualification; Method Transfer; Annual Method evaluations; Specification Setting; Laboratory Operations.
  • Provide support for Development QC testing and Pharmaceutical Analytical Development. Support for Studies and the samples used for the development and investigational studies.
Education & Qualifications

  • MS with 7+ years or BS with 10+ years and at least 5+ of relevant and supervisory experience.
  • Very strong relevant experience in executing, developing, and/or administrating GMP programs in cGMP biotech and/or pharmaceutical environments.
  • A minimum of 10 years in a cGMP biotech and/or pharmaceutical environment.
  • Strong Quality Control knowledge, previous experience in QC a plus.
  • Previous experience in other Quality Assurance functions is a plus.
  • Excellent interpersonal skills and the ability to communicate well orally and in writing.
  • Strong business acumen (Operations, productivity, continuous improvements).
  • Must be flexible.
  • Must be able to prioritize and multitask in a dynamic environment.
  • Fluency in English is required.
Desired Qualifications:

  • Quality experience in parenteral biotech manufacturing (aseptic or sterile processing).
  • Quality experience in drug substance manufacturing.
  • Able to perform functions in accordance with cGMP regulations.
  • Adherence to domestic and international guidelines, company policies and values.
  • Critical thinking/evaluation of process problems.
  • Data trending and evaluation.
  • Proactively address compliance issues and communicating compliance deficiencies to appropriate personnel/ management.
  • Ability to coach various customer departments in understanding compliance as well as complete gap analysis and develop appropriate action plans.
  • Proficiency with Microsoft applications Outlook, Word, Excel, Project, and Powerpoint; ability to learn additional software applications as the need arises.
  • Strong written and oral communication skills required.
  • Good interpersonal and teamwork skills required.
  • Strong organizational skills and detail oriented a must.
  • Ability to multi-task in a dynamic environment with changing priorities.
  • Strong work ethic.
  • Proactively addressing compliance issues and assuming responsibility for compliance deficiencies.
  • Ability to liaise professionally with regulatory agency personnel.
  • Ability to create, manage and improve complex Quality systems, integrating with existing systems.
  • Proficiency with Microsoft applications Word, Excel, Project, and Powerpoint; ability to learn additional software applications, as the need arises.
  • Ability to multi-task in a dynamic environment with changing priorities.
  • Ability to meet challenging timelines, in spite of obstacles, within budget
  • Strong prioritization and delegation skills.
  • Ability to think strategically and tactically, balancing these as workload changes.
  • Ability to delegate effectively and act commensurate with the position.
  • Self-motivated and driven to independently accomplish department goals and objectives.
  • Positive outlook and motivating, in spite of obstacles.
  • Understands the needs of key collaborators and customers, and interact effectively intra- and interdepartmentally to achieve alignment and consensus.
  • Must be capable of defining, implementing, and successfully defending sound QA systems approaches and principles.
  • Proven ability to organize complex work assignments and oversee analysts and staff to complete tasks and projects on time.
  • Coaching, influencing, active staff management, and conflict management skills, and active participation in team meetings.
  • Ability to interact professionally and effectively with peers, management, and leadership both within and outside the department, within the company, and business partners.
  • Possess excellent interpersonal and communication skills and provides leadership support to the department.
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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