Associate Document Advisor

3 weeks ago


Thousand Oaks, United States Collabera Full time

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.
Responsibilities:
  • 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
Education Qualification:
  • Bachelor's Degree in Biochemistry, Biology, Chemistry, or related science field
Required Skills:
  • 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
Basic Qualifications:
  • 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
Job Requirement
  • QA
  • CAPA
  • Batch record
Reach Out to a Recruiter
  • Recruiter
  • Email
  • Phone
  • Ruba Khokhar
  • ruba.khokhar@collabera.com


Apply Now

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