Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Job Description
This position is responsible for handling and implementing the processes associated with creation of new, and revision of existing, documents throughout the complete product lifecycle.
This position works with the appropriate groups and subject matter experts to ensure accurate product document content is developed. The position ensures compliance to internal documentation policies and procedures, and ensures product document content is consistent with health authority regulations. The position will be involved with responding to internal and external document audits and activities related to the development and maintenance of applicable procedures, guidelines, and document templates. Additionally, this position is responsible for the creation and delivery of training to pertinent functional units regarding document processes and supporting systems-based tools. Other duties and responsibilities include, but are not limited
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RESPONSIBILITIES:
Responsible for maintaining document management system aligned with regulatory, quality, and TDX requirements.
Analyze and recommend guidance on approved procedures, standardization and requirements associated with the label management system.
Be able to simultaneously and independently lead change control of assigned documents in a timely manner.
Implement initiatives to improve the document change management system.
Implement change control process so that only approved and validated changes are incorporated into effective product and process documentation.
Responsible for ensuring accuracy by reviewing documents for completeness, proper authorization and impact to other quality systems.
Collaborates with cross-functional departments to ensure timely implementation of document change requests.
Provide assistance with editing, formatting and final drafting of documents as requested and approved by supervisor.
Support audits (internal, external) in order to verify that regulatory and quality requirements have been met.
Act as back up Master Control Sub System Administrator.
Responsible for the management of all documentation and records issuance and archival processes to support clinical and commercial manufacturing.
Work independently, or with peers, to actively improve processes and procedures, as well as develop and implement solutions.
Minimum Requirements/Qualifications:
- HS Diploma/GED Required
- College Degree from an accredited higher learning institution is preferred.
- 2+ yrs of Experience in the Following:
- Direct technical writing experience desired.
- Quality systems demonstrated working knowledge in areas such as document management, document change control audits, and batch record issuance.
- Excellent organizational skills and ability to review processes or procedures.
- Ability to communicate and work independently with scientific/technical personnel.
- Experience in pharmaceutical or bio-pharmaceutical field.
- Solid understanding of quality systems and regulatory requirements (21 CRF Part 820; ISO 13485).
- Able to build presentations, work with spreadsheets, prepare reports and write procedures using MS Word, Excel, and PowerPoint software applications.
Compensation and Benefits
The salary range estimated for this position based in California is $66,000.00-$99,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
- A choice of national medical and dental plans, and a national vision plan, including health incentive programs
- Employee assistance and family support programs, including commuter benefits and tuition reimbursement
- At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
- Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
- Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards