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Quality Assurance Specialist

Townsend & Associates • Pennington, NJ

Posted 25 days ago

Job Snapshot

Contractor
Travel - None
Experience - At least 7 year(s)
Degree - 4 Year Degree
Competitive salary based on experience
Manufacturing, Pharmaceutical, Other Great Industries
QA - Quality Control, Pharmaceutical, Other
Relocation - No
75+

Applicants

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Job Description

Quality Assurance Specialist

Responsibilities:

 

  • Manage the timely release of incoming raw materials and consumables and for the assessment and closure of deviation investigations to ensure timely release of manufactured clinical products
  • Perform SAP transactions for material movements and disposition
  • Review and approve raw material specifications, raw material and test method qualification
  • Transfer documents and participate in vendor audits
  • Prepare and review quality agreements, vendor risk assessments, and new vendor approvals
  • Prepare quality metrics related to raw material release and deviation investigations for the routine quality council meetings
  • Manage deviation investigations related to raw materials, laboratory testing, GMP manufacturing operations and facility controls
  • Conduct routine cross-functional investigation review meetings to support the lead investigators and to ensure the timely deviation closure
  • Ensure that thorough investigations are conducted in accordance with SOPs and appropriate corrective and preventive actions are assigned to address the root cause with appropriate assessment of impact to product quality
  • Involved in authoring, review and approval of Standard Operating Procedures (SOPs) and other GMP documents
  • Provide quality representation at raw material planning meetings for new project launches and be part of the risk assessment teams
Quality Assurance Specialist

Job Requirements

Quality Assurance Specialist
W2 ONLY!!! 


Qualifications:

 

  • At minimum, a B.S. degree in a scientific discipline
  • Minimum of 7 years of related experience in the pharmaceutical or biologics industry with at least three years prior experience in Quality Assurance
  • An extensive knowledge and understanding of FDA, EU and ICH guidelines and cGMPs related to the manufacturing of biopharmaceutical product
  • Must have experience in managing investigations in a GMP manufacturing facility with familiarity in the use of electronic systems (i.e. TrackWise, SAP, LIMS and documentation management systems)
  • Ability to work independently with strong attention to detail, ability to drive performance and meet metric commitments and ability to make informed decisions that impact material or product release
  • Ability to be innovative, and help ensure high standards of quality and compliance are maintained at the site
  • Ability to work independently and demonstrate ability to exercise sound judgment in critical situations to assure compliance with regulations and procedures while working under tight timelines


Quality Assurance Specialist


Job ID: 17-01595
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