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Quality Assurance Contractor

Quality Assurance Contractor

Planet PharmaHouston, TX, United States
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Job Description

Quality Assurance Contractor

Job Responsibilities :

  • Review batch records
  • Perform line-clearance / change-over activities.
  • Disposition / Hold / Rejection of raw materials, starting material and in-house prepared materials.
  • Generate and reconcile in-process and Drug Product labels.
  • Review and approve executed documents related to manufacturing operations, QC and other departments.
  • Initiate and author deviations, CAPAs and Change Controls associated with Quality Operations practices.
  • Create, review, and approve procedures and practices within Quality Operations to implement quality standards.
  • Train employees on Quality Operations procedures and practices.
  • Other duties as required.

Preferred Qualifications

  • Bachelor's degree in a scientific field preferred
  • 3+ yrs. Related experience, preferable within QA or equivalent combination of education and experience.
  • Understanding of Cell and Gene Therapies.
  • Understanding of cGMPs, GLPs and GXPs.
  • Knowledge of local and global regulations.
  • Verbal and written communication skills.
  • Interpersonal and customer service skills.
  • Organizational skills and attention to detail.
  • Time management skills with a proven ability to meet deadlines.
  • Analytical and problem-solving skills.
  • Proficient with Microsoft Office Suite or related software.
  • 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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