Quality Senior Engineer
AbbVie
4 hours ago
On-site
Branchburg, NJ
Operations
Responsibilities:
- Implement and maintain the effectiveness of the Quality System.
- Ensure quality goals are met and practices/procedures comply with company policies and applicable regulations.
- Provide Quality support for core production, process improvement projects, new product/process launches, and automation systems; lead Quality and Compliance project activities.
- Provide Quality support for computer system/software-based validations; oversee data integrity initiatives (security, accuracy, consistency, completeness).
- Support Risk Management across quality system elements (e.g., Design Control, Product Surveillance, Field Action) and update risk management documents as needed.
- Ensure plant event investigations are thorough, accurately documented, included in the plant CAPA system; perform product impact analyses and place product on QA hold when appropriate.
- Maintain liaison with other Quality areas and Plant departments, including remote off-shift support as required.
- Approve standard operating procedures; ensure they comply with policy.
Qualifications:
- Bachelor’s degree, preferably in Biology, Chemistry, or Engineering.
- 6+ years of experience in Manufacturing, Quality, or Engineering.
- Good verbal and written communication skills.
- Strong problem-solving and analytical skills.
- Strong interpersonal/communication and negotiation skills.
- Knowledge of quality/compliance management and regulations/standards for API, bulk drug, or finished goods manufacturing.
Benefits (if applicable per posted job info):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k); eligible for short-term incentive programs.
- Implement and maintain the effectiveness of the Quality System.
- Ensure quality goals are met and practices/procedures comply with company policies and applicable regulations.
- Provide Quality support for core production, process improvement projects, new product/process launches, and automation systems; lead Quality and Compliance project activities.
- Provide Quality support for computer system/software-based validations; oversee data integrity initiatives (security, accuracy, consistency, completeness).
- Support Risk Management across quality system elements (e.g., Design Control, Product Surveillance, Field Action) and update risk management documents as needed.
- Ensure plant event investigations are thorough, accurately documented, included in the plant CAPA system; perform product impact analyses and place product on QA hold when appropriate.
- Maintain liaison with other Quality areas and Plant departments, including remote off-shift support as required.
- Approve standard operating procedures; ensure they comply with policy.
Qualifications:
- Bachelor’s degree, preferably in Biology, Chemistry, or Engineering.
- 6+ years of experience in Manufacturing, Quality, or Engineering.
- Good verbal and written communication skills.
- Strong problem-solving and analytical skills.
- Strong interpersonal/communication and negotiation skills.
- Knowledge of quality/compliance management and regulations/standards for API, bulk drug, or finished goods manufacturing.
Benefits (if applicable per posted job info):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k); eligible for short-term incentive programs.