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Quality Assurance Specialist

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Quality Assurance Specialist

  • Location:

    Hartsville, Pennsylvania

  • Sector:

    Manufacturing, Pharmaceutical

  • Job type:

    Direct Hire

  • Contact email:

    Tatiana McNeil

  • Job ref:

    9211

  • Published:

    about 1 month ago

  • Expiry date:

    2020-11-24

Quality Assurance Specialist

1st Shift

Hartsville, PA

Job Id: 9211

 

Are you looking to make a career change to a stable and innovative company? This exciting opportunity offers a competitive salary plus an excellent benefits package, including Medical, Dental, and Vision insurance and Paid Time Off. Does this position match your future career goals? Then this opportunity could be the right fit for you.

 

RESPONSIBILITIES:

  • Provide leadership, support, and oversight of environmental sampling/testing /reports, manufacturing, packaging, labels, material approval, and investigations review.
  • Review while updating SOP’s, policies, and processes regularly.
  • Ensure all quality standards comply with cGMP standards, FDA, and all competent authority.
  • Check and submit documents supporting manufacturing and development operations.
  • SOPs, QAPs, pre, and post executed batch records, and deviation reports.
  • Be the point of contact for the clients.
  • Perform regulatory audits, internal quality audits
  • Manage and maintain the vendor qualification program, schedule, and perform external audits.
  • Participate with write and approve investigations, deviations, discrepancies, technical problems, complaints, and non-conformances.
  • Record, execute reviews/audits, and approval.
  • Review results and prepare quarterly reports, annual summary reports, and biannual historical reports.
  • Review the process validation and equipment qualification protocols.
  • Understand approval of use for a Master Label and controlled labels
  • Provide input into Quality Systems while tracking: Deviations, Corrective and preventive actions, Change controls, Receipt of materials, Audit commitments, and other quality indicators.
  • Provide GMP training for the site, when required, and QA support and guidance to personnel across the area.
  • Perform QA supervisory functions, including approving timesheets, scheduling training, and approving paid/unpaid time off when applicable.


QUALIFICATIONS:

  • Bachelor’s degree in Science (BS/BA) Preferred
  • 5-7 years of Pharmaceutical experience.
  • Experience and training in this field or similar.
  • Equivalent combination of education and experience in this or similar.
  • Must have supervisory or leadership experienced.
  • Must understand aseptic processing and technology, including US compliance and regulatory requirements, required; working knowledge of EU requirements desired.
  • Must be able to stand for an extended period at a time.
  • Must know cGMPs, FDA & DEA, US, and EU Regulations.
  • Must be able to work independently.
  • Must be able to multi-task.
  • Must be able to negotiate and meet critical timelines
  • Must be detail oriented and have strong organizational skills.
  • Excellent oral and written communication
  • Proficient in MS Suites, Adobe Acrobat, and document management software is a plus.

 

BENEFITS:

  • Medical Insurance
  • Dental Insurance
  • Vision Insurance
  • PTO
  • Direct Hire

 


Ask for: Tatiana McNeil

tatiana@ajuliaexecutivesearch.com

Ajulia Executive Search is a New Jersey-based Executive Search Firm specializing in retained searches in multiple sectors, including Manufacturing, Finance, IT, Legal, and Pharmaceutical. We have a nationwide client base and offer services in temporary and direct hire placements.


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