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QA Compliance Specialist

Harrow
Ledgewood, NJ
  • Expired: over a month ago. Applications are no longer accepted.
Job Description
At Harrow Health, Inc. (Harrow) we are working hard to help our customers navigate the realities of the healthcare market by providing innovative medications that address both clinical and economic needs. To get there, we need exceptionally talented, bright, and driven people. If you would like to help us build and maintain a quality culture organization that supports the growth of the company and is trusted by healthcare professionals from across the US, this is your chance to join us.

The Quality Assurance Compliance Specialist will meet the company goals for product quality and production efficiency. This position will ensure that the operations are following the cGMP standards promulgated under Section 503B of the US Food, Drug & Cosmetic Act. The QA Compliance Specialist will participate in audits and inspections and will be responsible for writing and/or managing all deviations, CAPAs, product complaints and change controls at the site.

Responsibilities
  • Participates in regulatory audits, assists in maintenance of audit records and documenting follow-up from audits.
  • Responsible of writing and/or managing investigations/deviations.
  • Performs or assists process owners with the root cause analysis.
  • Responsible of generating and monitoring CAPA's and change controls for the site.
  • Prepares and monitors Quality Metrics and KPI's.
  • Perform visual inspection of injectable vials.
  • Performs duties in accordance with established company procedures and policies; performs other duties as assigned.
Qualifications
  • Recent experience with aseptic drug product manufacturing is preferred.
  • A fundamental, working knowledge of safety, quality systems, and quality assurance concepts is required including the application of current Good Manufacturing Practices and Good Documentation Practices.
  • Familiarity with manufacturing process and operations, automation, equipment/facilities validation.
  • Familiarity with FDA inspections and audits
  • Investigation writing skills.
  • Ability to complete tasks with little direction or need for supervisory follow-up.
  • Strong written, verbal and presentation communication skills.
  • Strong computer skills in database management and documentation preparation (Word, PowerPoint, Excel, and other must be able to learn additional software as required).
  • Ability to think creatively in confronting new issues and pursuing novel approaches to old problems.
  • Ability to work under pressure, meet deadlines and exercise sound business judgment with critical thinking skills and high ethical standards.
  • Work schedule flexibility

Experience

  • 5-7 years of progressive experience within cGMP quality operations and FDA regulations or a 503B outsourcing facility, aseptic/parenteral manufacturing/development environment or equivalent technical experience.

Education/Training

Bachelor’s degree in Science, Microbiology, or Engineering or related field or equivalent work experience required



Harrow

Address

Ledgewood, NJ
07852 USA

Industry

Technology