Senior Quality Engineer, Risk Management
AbbVie
4 months ago
Remote friendly (Branchburg, NJ)
United States
$78,500 - $141,000 USD yearly
Operations
Responsibilities:
- Maintain liaison with AbbVie Quality, Regulatory, Technical, Supply Chain, and TPM sites.
- Ensure bulk drug substance/drug product production at TPM sites follows current GMP, local procedures, and AbbVie QA Operations manufacturing directions.
- Ensure TPM procedures (raw material/product specifications, test methods, supplier change notification, shipping) comply with cGMP, policies, regulatory approvals, and the Quality Technical Agreement.
- Review and approve manufacturing directions to the production floor.
- Support PQA in global projects/events; include planning, risk analysis, and implementation.
- Ensure thorough, accurate investigations of TPM plant events (process, laboratory, raw materials), including product impact analyses and CAPA documentation.
- Perform annual Product Quality Reviews per AbbVie global procedure.
- Participate in Trend Review Board to monitor process track and trending.
- Participate in Global Change Review Board (GCRB) as TPM representative to evaluate global changes affecting all sites.
- Generate detailed change management plans for TPM plant changes; include planning, risk analysis, and implementation.
Qualifications:
- Bachelor’s degree (preferably Engineering or Science).
- 6 years pharmaceutical operations experience, preferably biologics manufacturing.
- Knowledge of GMP regulations/standards for pharmaceutical products.
- Comprehensive knowledge and application of business and quality concepts.
- Strong analytical skills and attention to detail.
- Change plan, Exception Reports, SAP and LRMS experience highly preferred.
- Ability to adapt communication for multicultural audiences.
- Strong interpersonal/communication skills across all organizational levels.
- Maintain liaison with AbbVie Quality, Regulatory, Technical, Supply Chain, and TPM sites.
- Ensure bulk drug substance/drug product production at TPM sites follows current GMP, local procedures, and AbbVie QA Operations manufacturing directions.
- Ensure TPM procedures (raw material/product specifications, test methods, supplier change notification, shipping) comply with cGMP, policies, regulatory approvals, and the Quality Technical Agreement.
- Review and approve manufacturing directions to the production floor.
- Support PQA in global projects/events; include planning, risk analysis, and implementation.
- Ensure thorough, accurate investigations of TPM plant events (process, laboratory, raw materials), including product impact analyses and CAPA documentation.
- Perform annual Product Quality Reviews per AbbVie global procedure.
- Participate in Trend Review Board to monitor process track and trending.
- Participate in Global Change Review Board (GCRB) as TPM representative to evaluate global changes affecting all sites.
- Generate detailed change management plans for TPM plant changes; include planning, risk analysis, and implementation.
Qualifications:
- Bachelor’s degree (preferably Engineering or Science).
- 6 years pharmaceutical operations experience, preferably biologics manufacturing.
- Knowledge of GMP regulations/standards for pharmaceutical products.
- Comprehensive knowledge and application of business and quality concepts.
- Strong analytical skills and attention to detail.
- Change plan, Exception Reports, SAP and LRMS experience highly preferred.
- Ability to adapt communication for multicultural audiences.
- Strong interpersonal/communication skills across all organizational levels.