Quality Documentation Specialist (eDMS/Veeva) (Pharma/Biotech/Medical Device)

PHD will be overqualified for this role

candidates must have more hands on experience with eDMS (Creation, revision, routing, etc.).

Recent Experience with quality documents and Veeva Vault and all documentation related activities, experience with migrations is a plus

Hybrid role (3 days onsite and 2 days remote)

Open for candidates who are ready to relocate at their own expense

QA documentation role

More years of exp will also work (10 yrs exp will also work)

• Associates degree will work
• Aerospace industry exp will not work
• Working with cross functional teams
• Veeva exp 1 year
• 2 yrs exp needed with EDMS
• Maintain EDMS
• Document will be in client format
• Creation and revision of documents
• Assist with creating, routing, formatting, reformatting documents
• Getting documents approved in EDMS
• Will not be authoring documents from scratch
• Will be working cross functionally with SME
• EDMS exp is a must have (Veeva preferred) (Documentum or opentext)
• 4 yrs of GMP exp
• GMP exp needed
• Pharma or medical device industry experience will be considered
• Bachelor’s degree preferred in science or engineering or technical
• Master’s degree will also work

The role is a Hybrid position (3 days onsite, 2 days remote)

• This position provides assurance of adherence to Client documentation standards and principles.
• The role is primarily responsible for managing the creation and revision of Quality System and processes documents including assessment of proposed changes taking all controlled documentation and processes into account.
• Furthermore, acts as Subject Matter Expert for Quality documentation administration (Change Control) and is the interface between RDQA QS Documentation Management group and supported R&D functions.

Key Accountabilities/Core Job Responsibilities:

• Provides client with understanding of the Client Quality System and its practical application. Participates in global compliance and continuous improvement projects related to Quality System documentation.
• Ensures compliance during QS documentation creation and revision and is accountable for content design and logistics of multi- and cross-functional documentation review and approval.
• Supports development of strategy for creation of complex QS procedural documents involving cross-functional teams.
• Ensures all administrative documentation requirements are met for supported Quality Documentation inclusive of document processing and records management.
• Facilitates the creation/revision, administration, review, and approval (as applicable) of new and revised Quality Documentation within the Document Management System (DM) Maintains notifications, relations, and other property information within the Document Management System (DMS).
• Participates in supporting R&D project and initiatives and continuous improvement projects related to documentation management as applicable.
• Supports and coordinates of document translation process (incl. Translation checking (LU only) as applicable.
• Collects and reports documentation-related key performance indicator metrics.
• Provide input into overall team strategy and framework development for new and emerging initiatives (incl. mid- and long-term team goals).

Qualifications (Education and Experience)

• Bachelor's degree (technical/scientific area preferred) or equivalent experience.
• Minimum 4 years of pharmaceutical experience in a GMP environment administering
• Document Control Systems 1-2 years’ experience using and administering electronic document management tools.

Specific Skills/Abilities

• Basic understanding and knowledge of GxP requirements and pharmaceutical regulations preferred.
• Advanced knowledge and hand-on experience with Document Management Systems OR other database applications
• Advanced organizational skill,
• Attention to detail Experience with Microsoft Office products, incl MS Word processing / formatting experience
• Advanced spoken and written English skills (OUS only)) Excellent verbal and written communication and interpersonal skills Strong independent contributor and team member in a fast-paced environment.
• Ability to work effectively in a team environment.
• Builds strong relationships with peers and cross-functional partners to enable timeline completion of document lifecycle.
• Detailed oriented with solid problem-solving acumen.

Job Type: Contract

Pay: $43.00 - $45.00 per hour

Expected hours: 40 per week

Benefits:

• Flexible schedule
• Health insurance
• Life insurance
• Paid time off

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• change control: 5 years (Preferred)
• Pharma or biotech or medical device industry: 4 years (Preferred)
• Quality assurance documentation: 4 years (Preferred)
• eDMS (Electronic Document Management Systems): 4 years (Preferred)
• Veeva Vault: 4 years (Preferred)

Ability to Commute:

• Irvine, CA 92602 (Required)

Work Location: In person

Salary : $43 - $45