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Associate Document Advisor
4 months ago
Description
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Associate Document Advisor
Contract: Thousand Oaks, California, US
Salary: $37.00 Per Hour
Job Code: 349495
End Date: 2024-06-15
Days Left: 25 days, 3 hours left
Apply
Pay range: $30 to $36/hr
About the Role:
- This position supports the Quality Assurance program under the Plant QA organization, providing daily oversight of the Drug Substance manufacturing areas.
- The Sr. Associate will be responsible for supporting and ensuring compliance with Manufacturing and Facilities & Engineering processes, procedures, and quality systems.
- This role involves tasks such as electronic batch record review, SOP revision & approval, work order approval, and quality approval of minor deviations and CAPA records.
- The Sr. Associate will also evaluate compliance issues, provide recommendations, and oversee the progress of quality records to completion.
- Additionally, they will represent the Drug Substance Quality Assurance department in project execution to achieve operational goals in a team matrix environment.
- Provide support and compliance oversight to Manufacturing and Facilities & Engineering areas/staff
- Conduct purposeful presence on the manufacturing floor
- Review electronic batch records and approve SOPs, work orders, and quality records
- Evaluate compliance issues, provide recommendations, and ensure completion of quality records
- Represent the Drug Substance Quality Assurance department in project execution
- Work in a team matrix environment to achieve departmental operational goals
- Bachelor's Degree in Biochemistry, Biology, Chemistry, or related science field
- Ability to perform GMP operations and make quality based decisions Experience managing projects and meeting timelines
- Proficiency in evaluating documentation and operations according to company procedures
- Familiarity with Quality Systems and strong organizational skills
- Ability to manage multiple tasks simultaneously
- Effective communication skills (both written and verbal)
- Ability to work both independently and as a team player
- Display leadership attributes and drive improvement initiatives
- Solid understanding and application of aseptic behaviors and principles
- Master's degree OR Bachelor's degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
- QA
- CAPA
- Batch record
- Recruiter
- Phone
- Ruba Khokhar
- ruba.khokhar@collabera.com
Apply Now
