QMS Investigator - Astrix Technology : Job Details

QMS Investigator

Quality Control

Middlesex County, NJ, US

Pay Rate Low: 35 | Pay Rate High: 37

+ Added - 16/10/2024

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Our client - a global biopharmaceutical company - is seeking a QMS Investigator to join their growing team!

**Type:** Contract-to-hire

**Pay:** Up to $37/hr

**Location** : Middlesex County, NJ

**Duties:**

+ Perform all analytical testing activities within a GMP-compliant environment while collaborating with cross functional teams.

+ Ensure proper chain of custody for samples received in QC.

+ Develop and manage weekly schedules for QC analysts.

+ Author, review, and revise technical documents (protocols, specifications, reports, SOPs, test methods, memos, and impact assessments).

+ Conduct laboratory investigations, including experiments, and write thorough investigation reports with scientific justification and root cause analysis.

+ Review/perform equipment calibration, validation, and maintenance records to ensure timely and accurate completion.

+ Optimize, validate, and manage the transfer of cell-based assays from R&D or external labs to the QC lab.

+ Operate testing instruments: HPLC, GC, UV, ICP-MS, FTIR, TOC, CE, ICE, Karl Fisher, VHP Isolator, Plate Reader, etc., during testing.

+ Perform laboratory techniques: qPCR, ELISAs, and other relevant methods.

+ Assist in the creation, review, and closure of Change Control records.

+ Conduct quality testing, review QC data, and prepare Certificates of Analysis.

+ Maintain and review quality records.

+ Train and assist junior QC team members. Manage, coach, and mentor direct reports to ensure completion of training curricula.

+ Monitor and maintain quality metrics for stability testing.

+ Apply problem-solving and statistical analysis tools to drive root cause identification and process improvement.

+ Initiate and investigate OOS, OOT, and lab incidents.

**Qualifications:**

+ Bachelors degree with 12+ years of experience in QC or related roles in the pharmaceutical/biopharmaceutical industry.

+ M.S. with 8+ years of industry experience in QC or equivalent roles.

+ Comprehensive knowledge of cGMP in pharmaceutical/biopharmaceutical settings.

+ Experience in inspection readiness for audits.

INDBH

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.