Document Control QA Associate

Document Control QA Associate Needed in Westlake Village, CA

Industry:
BioTech

Schedule:
Monday - Friday from 7:30am - 4:00pm

Pay Range:
$21 - $22/hour

Term:
Temp-to-Hire

Job Summary

The Document Controller is responsible for supporting the Quality Assurance Department by ensuring compliance with Drug GMP standards across plant and laboratory operations. This role manages controlled documents, prepares and issues SOPs, organizes production and technical records, reviews batch documentation, and assists with product quality reviews. Additional responsibilities include monitoring production lines, evaluating customer complaints, and maintaining training and calibration records.

Key Responsibilities

* Issue, approve, and review packaging and in process batch records.

* Maintain batch record filing system, including reconciliations and final documentation.

* Draft and revise SOPs across departments; maintain SOP files and audit systems.

* Update controlled documents requiring revisions.

* Investigate and evaluate customer complaints; maintain complaint records.

* Monitor production and shipping lines as needed.

* Compile data for annual product reviews.

* Prepare International Certificates of Analysis (COAs) and review international orders.

* Maintain employee training files and databases.

* Calibrate thermometers and update calibration records.

* Perform daily temperature checks, monitor deionized water, and conduct dissolved solids testing.

* Conduct finished product evaluations, retained sample examinations, and manage product disposal/testing.

* Review and approve packaging materials and label prints for production use.

* Conduct physical appearance examinations of products.

Additional Duties

* Serve as backup for flask inoculation, cell weighing, oil dumping, and solids testing.

* Assist with preparing and issuing formulas to production.

Qualifications

* Bachelor of Science in Microbiology or related field, OR Associate degree with equivalent experience in cGMP manufacturing, document control, or quality assurance.

* Strong knowledge of QA/QC procedures, laboratory analyses, and SOP management.

* Familiarity with production processes, raw materials, and quality control standards.

* Proficiency in clerical and administrative systems, including document management.

Skills & Abilities

* Quality control analysis, troubleshooting, and data evaluation.

* Strong written and verbal communication skills.

* Critical thinking and problem sensitivity.

* Time management and organizational skills.

* Ability to monitor processes, analyze data, and ensure compliance with GMP standards.

Work Environment & Physical Requirements

* Frequent sitting, standing, walking, bending, and lifting (up to 30 lbs).

* Requires fine hand manipulation, grasping, pushing/pulling, and intermittent overhead reaching.

* Visual requirements include reading lot numbers, computer work, and document review.

* Standard laboratory and office environment with minimal exposure to mechanical or airborne hazards.

*All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated

Los Angeles county

, to the extent our customers

require

a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.*