3 дня назад
Quality Systems Supervisor - Document Control (GMP)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Systems Supervisor - Document Control (GMP): Overseeing site document control operations, electronic document management, quality records, and GMP-compliant documentation with an accent on team leadership, document lifecycle management, and audit readiness. Focus on administering Documentum or similar systems, approving quality records, improving processes, and supporting regulatory inspections.
Location: On-site in Pearland, Texas; listed location is Houston, Texas. Schedule: Monday through Friday, 8:00 am–5:00 pm.
Compensation: Competitive salary; performance-related bonus. Amount not specified.
Company
is a life sciences company with more than 30 sites across five continents that manufactures medicines and supports the development of therapies.
What you will do
- Supervise document control operations, including controlled document issuance, change control, electronic workflows, archival, and record retrieval.
- Serve as the site QA Document Control contact and collaborate with research, quality, and process development teams.
- Own and administer electronic document management systems such as Documentum, including configuration, user setup, and troubleshooting.
- Lead, coach, develop, hire, and onboard Document Control team members and contractors.
- Develop procedures, implement process improvements, and report document control metrics to leadership.
- Review and approve quality records, including change controls, deviations, CAPAs, investigations, and controlled documents; support audits and regulatory inspections.
Requirements
- 3–5 years of experience in document control, quality systems, or a related GMP-regulated environment.
- GMP experience is required.
- Strong understanding of document control processes and quality systems.
- Prior leadership, team supervision, issue resolution, and process improvement experience.
- Ability to manage multiple priorities and collaborate across departments in a fast-paced environment.
- Proficiency with spreadsheets, databases, document systems, and standard business software.
Nice to have
- Bachelor’s degree.
- Experience with Documentum, Veeva, or similar document management platforms.
- Previous lead or supervisory experience.
Culture & Benefits
- Performance-related bonus.
- Medical, dental, and vision insurance.
- 401(k) matching plan.
- Life insurance and short- and long-term disability insurance.
- Employee assistance programs and paid time off.
- Work environment centered on collaboration, accountability, excellence, passion, integrity, and equal employment opportunity.
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