Duties and Responsibilities:

• Perform Quality oversite of computerized systems, including review/approval of qualification documentation, and ensuring compliance with routine maintenance of computerized systems (e.g. audit trail review, user accounts, data integrity configuration, and data backup/recovery) of new software implementations and maintenance of existing systems
• Perform risk assessments with functional teams to assess system risks and develop mitigation plans
• Provide input to GxP assessments for 21 CFR Part 11/Data Integrity requirements
• Review and approve computer system change controls, discrepancies, CAPAs
• Provide expertise in CSV compliance, manage identified issues, and support continuous improvement.
• Support inspection readiness programs and/or directly support regulatory agency inspections. Assist in the coordination of response to any findings as applicable.as required/assigned for this position.
• Assist Document Control as necessary
• Write, review, edit revised SOPs / Forms as applicable
• As assigned, execute various tasks independently, or with minimal supervision for any of the associated quality systems:
  • Training
  • Documentation Control
  • Information Technology
  • Auditing
  • Quality Control Support

• Ensure Quality System, cGMP and ICH guidelines are followed on site. Help with annual analysis of upgrades to Quality System in terms of both Operations efficiency as well as new FDA or ICH regulatory changes.
• Partner with Regulatory Affairs, Manufacturing, Development, Marketing as well as Corporate Quality on customer projects, regulatory submissions, and harmonization of PPL Group’s Global Quality standards across PPL Group sites.
• Perform other tasks as assigned.

Qualifications:

• Bachelor's degree (Life Science, Engineering, Science or similar technical discipline preferred)

• Minimum 2-5 years of experience working in the Biotech/Pharmaceutical industry in Quality Compliance or Computer System Validation roles.
• Strong knowledge in 21 CFR Part 11, GAMP5, electronic record/electronic signature, and data integrity requirements, standards and guidelines.
• Strong background and understanding of FDA regulations.
• Knowledge of Good Clinical practice (GCP), Good pharmacovigilance Practice (GVP), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP).
• Experience in authoring/reviewing/approving validation documentation.
• Experience supporting enterprise software deployments and laboratory/manufacturing equipment and instruments (such as HPLC, MES, ERP, DMS, QMS, etc.)
• Excellent written and verbal communication skills with ability to work with cross-functional teams.
• Experience with vendor audits, quality agreements
• Ability to manage multiple projects

Salary: $28-$38 per hour

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.