GQR | Quality Assurance Associate 2nd Shift | lexington, ky

2 days ago

lexington, United States GQR Full time

Title: Quality Assurance Associate 2nd Shift

Location: Lexington, MA

Shift: 2nd Shift, 3 pm to 11pm Monday through Friday

Status: 6-12 month contract

Hourly rate: $55 an hour


Please note, this is Quality Assurance role and not a QC role. Qualified candidates must have experience working in a QA role on the manufacturing floor. Additionally, this contract cannot be done on C2C or offer sponsorship of any kind.


Quality Assurance Associate

This individual in this office-based role will maintain on site quality presence at GMP facility in Lexington, MA by providing support for clinical phase manufacturing, batch record review and quality issue resolution. Will also support incoming raw material/excipient release, document management and training systems. Primary function is to assure the quality of manufactured products is in compliance with all applicable regulations, guidelines and internal procedures.


Responsibilities:

• Proactively promote GMP, GDP, and compliance concepts.

• Support incoming raw material release.

• Support Supply Chain and Manufacturing with dispensing of raw material for batch production.

• Support QC, Analytical Research and Development (ARD) with CoA review, approval, and filing.

• Perform quality oversight of clinical phase manufacturing executional compliance with GMP, including issuance of production batch records, line clearance, QA on the floor presence, raw material, component, and in-process material checks.

• Support batch documentation review, deviations/investigations, change control and issue resolution for Intermediate and Drug Product (DP) Disposition.


Qualifications:

Minimum of BA/BS in a science related field

• Minimum of 5 years of related work experience in pharmaceutical, biotech or medical industry

• Knowledge of Good Manufacturing Practices (GMPs), Good Documentation Practices and application within pharmaceutical development.

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