QA Document Control Specialist Job Summary
Assists in maintaining a compliant, efficient Quality Assurance Document Management program. Job Responsibilities
Education & Qualifications
- Under direct supervision, perform day-to-day Document Control activities:
- Process DCR packages and review for correctness and completeness
- monitor and update in-process documents
- create, assign and archive QA controlled lab notebooks and logbooks
- assist in managing the electronic document management system
- assist in managing access to Master Documents in the Document Control Vault
- create reports
- Performs duties in support of established records management procedures, including scanning, filing and managing offsite records storage and retrieval. Participate in internal audits
- Assist in updating SOPs
- Participate in regulatory inspections
- Provide user assistance with using the Electronic Document Management System
- High school diploma with 2 years of general document control experience
- 0-2 years of pharmaceutical experience in a GMP environment. (medical device experience does not translate well).
- 0-2 years experience using and administering electronic document management tools
- General knowledge of electronic documentation systems, data retrieval, and electronic file formats.
- Working knowledge of Quality Systems, GMP-related requirements and ICH guidelines, desirable.
- Willing to learn new areas of responsibility.
- Detail oriented with solid problem solving acumen.
- Ability to work effectively in a team environment.
- Ability to analyze and reconcile moderately complex issues.
- Must have demonstrated initiative and accountability in a fast paced environment.
- Excellent verbal and written communication and interpersonal skills.
- Proficient with computers and word processing software (i.e. Microsoft Office products).
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.