Documentation Control Lead

24 hours ago


New Brunswick, New Jersey, United States Verista Full time
Job Summary

Verista is seeking a skilled Documentation Control Lead to join our team. As a key member of our quality assurance team, you will be responsible for managing validation documentation in automated systems, performing quality reviews of IQ/OQ/PQ protocols, and collaborating with cross-functional teams to ensure documentation aligns with project milestones.

Key Responsibilities
  • Manage validation documentation in automated systems, including document control and archiving.
  • Perform quality reviews of IQ/OQ/PQ protocols, test scripts, and validation reports.
  • Collaborate with the CQV and engineering teams to ensure documentation aligns with project milestones.
  • Assist in audits and inspections by providing necessary documentation.
  • Ensure all document control activities comply with FDA, cGMP, and internal quality standards.
Requirements
  • Bachelor's degree in Life Sciences, Engineering, or related field.
  • 8+ years of experience in document control and quality assurance in pharmaceutical settings.
  • Expertise in validation documentation management and quality review processes.
  • Strong understanding of regulatory requirements, including FDA and cGMP.
  • Excellent attention to detail and organizational skills.
  • Proficiency using PC and Microsoft Office tools.
  • Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms.
  • Ability to work as part of a team.
  • Strong problem-solving and critical thinking skills.
  • Excellent organizational and time management skills.
  • Strong attention to detail
What We Offer
  • Competitive pay plus performance-based incentive programs.
  • Company-paid Life, Short-Term, and Long-Term Disability Insurance.
  • Medical, Dental & Vision insurances.
  • FSA, DCARE, Commuter Benefits.
  • Supplemental Life, Hospital, Critical Illness and Legal Insurance.
  • Health Savings Account.
  • 401(k) Retirement Plan (Employer Matching benefit).
  • Paid Time Off (Rollover Option) and Holidays.
  • As Needed Sick Time.
  • Tuition Reimbursement.
  • Team Social Activities.
  • Employee Recognition.
  • Employee Referral Program.
  • Paid Parental Leave and Bereavement.

For more information about our company, please visit us at


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