Gmp Quality Specialist Jobs in Massachusetts

Working knowledge and technical understanding of the manufacturing and testing of biologics or Cell and Gene therapy highly desired.

Paper batch records (drug substance or drug product) review and batch disposition experience is a plus.

EnsuresthatManufacturing F acilities andEquipment arecompliant withcGMP requirements:

Agenus is Delighted to Provide you With a Comprehensive Benefits Plan, Including Some of the Following:

Performs line clearances for all manufacturing runs in the Cleanroom. Must be willing to gown.

Verifies Leukopak Receipt. QA primary contact for verification of release of starting material performed by Supply and Logistics for GMP production

Excellent interpersonal skill with knowledge of basic negotiation, influencing and conflict management to assure effective interactions within and across departments.

Ability to manage multiple projects in a dynamic environment.

Experience with using risk-based principles and decision making to ensure compliance at all stages of development.

Assure compliance (internally and externally) with 21 CFR 210/211, 312, EudraLex Vol. 4 (including relevant parts and annexes) and ICH.

Provide GMP oversight of daily quality related tasks and priorities of the clinical and commercial partners.

Review and Approve Master Batch Production Records and Executed Batch Production Records.

General knowledge of CMC and Regulatory Filing requirements.

Minimum 1 year of experience within the Pharmaceutical or Biotechnology industry in a Quality role. QC experience is a plus.

Experience with small molecules and oral dosage forms is highly preferred.

Knowledgeable in FDA cGMP regulations, EudraLex and ICH Guidance, as well as other Biopharma industry guidance and regulations.

Clinical knowledge in neurodegenerative diseases (i.e., ALS, Alzheimer's disease).

Experience in supporting functions during FDA, EMA, or other regulatory agency inspections.