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Quality Assurance Associate

Quality Assurance Associate

Planet PharmaSanford, NC, United States
3 days ago
Job type
  • Full-time
Job description

Job Description

The Specialist, QA Validation will be primarily responsible for the implementation, execution and assessment of quality systems, procedures, and records to support compliant GMP operations. This position works closely with Validation, Engineering, Manufacturing, Quality Control, Facilities, and Automation.

Responsibilities and Accountabilities :

  • Provide hands on QA support and oversight to internal staff and suppliers / contractors to ensure compliance with local and global quality standards, regulatory requirements, and industry guidance.
  • Provide QA review and approval for commissioning / qualification / validation documents.
  • Provide QA review and approval of qualification and validation deviations and discrepancies and support investigation and corrective actions.
  • Author, review and approved controlled documents for the Quality organization including SOPs, specifications, protocols, and reports.

Qualifications :

  • B.S. degree in Biological / Physical / Chemical sciences, engineering, or equivalent focus of study and 3-5+ years of experience or M.S. degree and 1-3+ years of experience in a QA function in a biologics manufacturing facility
  • Experience with qualification / validation of process equipment, analytical instruments, clean utilities, automation, sterile filling, and clean facilities.
  • Strong understanding of FDA, EMA, local regulations and guidelines, ICH guidelines, and industry best practices.
  • Successful history working in a fast-paced team environment, meeting deadlines, and prioritization of work from multiple projects
  • Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others
  • Excellent problem-solving skills and experience with root cause investigations and CAPA determination
  • Off hours coverage and flexibility may be required
  • Equal Opportunity Employer : We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

    Fraud Alert : Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.

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    Quality Assurance Associate • Sanford, NC, United States