Quality Assurance Specialist III

LanceSoft Inc; Lexington (MA); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading biotech firm in the United States is looking for a Quality Assurance Professional to oversee contract manufacturing and testing of biologics products. This role requires at least 5 years of experience in a cGMP environment, with strong skills in compliance documentation and Quality Control. The ideal candidate possesses excellent communication abilities and a flexible work ethic. The position provides an opportunity to contribute to quality assurance processes while working collaboratively within a dynamic team.

Qualifications

• Minimum of 5 years in a cGMP biotech and/or pharmaceutical environment.
• Experience in Biologics manufacturing or Quality Control.
• Flexibility and adaptability in a dynamic environment.

Responsibilities

• Perform QA oversight for CMO and CTL in drug manufacturing.
• Interface with CMO and CTL for compliance documentation.
• Compile and track CMO and CTL metrics and deliverables.

Skills

GMP programs

cGMP biotech experience

Quality Control knowledge

Excellent communication skills

Strong business acumen

Organizational skills

Teamwork skills

Job description

Description

The Quality Assurance Professional will work in the US External QA team responsible for Contract Manufacturing (CMO) and Contract Test Laboratories (CTL) oversight within the Biologics Operation Unit Quality Assurance Department . This unit oversees contract manufacturing (3rd party manufacturing) operations of Drug Substance and Drug Products. This unit also provides QA support for Contract testing Laboratories as well as internal Quality Control.

Primary responsibilities include: CMO and CTL QA oversight for the manufacture and testing of commercial biologics products. Interfacing CMO for site compliance documentation, quality systems review (deviations, CAPA, Change control), Supplier Notifications of Change, coordination of executed batch documentation, master batch record review, business management review meetings, APR review, audits, Quality agreement author/reviewer. Interfacing with CTL and internal QC for testing protocol/report review and deviation/CAPA/Change Control review. Other responsibilities include compiling and tracking CMO and CTL metrics, data, and deliverables.

Experience with GMP programs in cGMP biotech and/or pharmaceutical environments. A minimum of 5 years in a cGMP biotech and/or pharmaceutical environment.

Quality experience in Biologics manufacturing and/or Quality Control knowledge, required. Previous experience in other Quality Assurance functions is a plus. Excellent interpersonal skills and the ability to communicate well orally and in writing. Strong business acumen (Operations, productivity, continuous improvements). Must be flexible. Must be able to prioritize with minimal supervision.

Good interpersonal and teamwork skills required. Strong organizational skills and detail oriented a must. Ability to multi-task in a dynamic environment with changing priorities. Strong work ethic.

Additional Information

All your information will be kept confidential according to EEO guidelines.