Sr. Document Control QA Specialist

Highly Competitive Salary
  1. Permanent
  2. Senior/Director & VP, Good Distribution Practice (GDP), Good Pharmacovigilance Practice (GVP)
  3. United States
San Diego, USA
Posting date: 09 Sep 2021
QA.JZ.39863

This vacancy has now expired. Please see similar roles below...

Proclinical is working with our client on an exciting opportunity to join a growing biotech company in San Diego! This isn't your average Document Control position; this role will wear many hats and be trained in several areas of QA! This position will require being onsite in the San Diego (Mira Mesa) office. It is a hybrid schedule, 3 days in office/2 days work from home. Please do not apply if you want a remote only position.

Job Responsibilities:

  • Associate's degree or higher, Bachelor's degree preferred
  • Manage document control, deviations and change control and training processes for GXP activities.
  • Support audit scheduling and records for all GXP activities.
  • Prepare and handle documents and procedures for review, approval, and execution.
  • Develop, review and revise documentation procedures.
  • Establish and maintain records management process including scan, storage, archival and retention.
  • Support deviation and change control activities to ensure timely approval and closure.
  • Oversee on boarding and on-going training program, tracking and maintaining training records

Skills and Requirements:

  • Knowledge of GXP and GDP regulatory requirements.
  • Strong collaboration, strategic thinking, leadership, and teamwork skills.
  • EDMS experience

If you are having difficulty in applying or if you have any questions, please contact Jax Zafrani at (+1) 213-893-4997 or j.zafrani@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-JZ1

close