Description
Pharmaceutical Senior Quality Engineer opening onsite in Somerset, NJ.
Provide Quality oversight activities for the aseptic fill manufacturing site. Provide Quality Assurance technical expertise to ensure aseptic manufacturing facility, processes and support systems are in compliance with company guidelines and CGMP regulations for marketed products and/or their raw materials, APIs, excipients or components.
Key Responsibilities/Essential Functions
- Function as the primary QA representative in investigation and CAPA review and approval, both internally and externally.
- Collaborate with full range of personnel in manufacturing and technical work teams that support Production to identify root cause of a problem and determine appropriate corrective action for investigations.
- Consult with a range of internal, external and collateral contacts to correct non-routine and, or comprehensive issues, identify trends and determine corrective actions. Make recommendations that meet multiple technical, regulatory and business requirements.
- Review and approve protocols, validation documents and procedures, both internally and externally.
- Resolve unique and/or adverse situations, gather and review information from diverse functional areas, and make appropriate quality recommendations based on evidence.
- Provide leadership and technical expertise in conducting investigations and making recommendations for targeted data and information collection as required for quality events. Contributes to data and information collection.
- Act as technical resource with the FDA and other government agencies during site inspections.
- Alert management of critical issues that have significant impact to manufacturing objectives and timelines, while providing a range of achievable solutions.
- Approve change controls and support Change Control Board meetings as required.
- Represent QA in a range of team meetings, processes and initiatives both internally and at CMOs.
- Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.
- Actively demonstrates the values of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety and teamwork.
- Remain current and apply knowledge of FDA CFR 210/211 and other regulatory standards and guidance in the pharmaceutical industry
- * In the case of absence the reports to Manager above or a peer incumbent will function as a backup for this position.
Basic Qualifications
- BS/BA degree in a scientific discipline with minimum 5 years of progressive experience in the pharmaceutical or radiopharmaceutical industry or related GMP environment, or equivalent.
Other Requirements
- Aseptic fill-finish experience, including familiarity with validation of aseptic manufacturing technologies and facilities is preferred.
Provide Quality oversight activities for the aseptic fill manufacturing site. Provide Quality Assurance technical expertise to ensure aseptic manufacturing facility, processes and support systems are in compliance with company guidelines and CGMP regulations for marketed products and/or their raw materials, APIs, excipients or components.
Key Responsibilities/Essential Functions
- Function as the primary QA representative in investigation and CAPA review and approval, both internally and externally.
- Collaborate with full range of personnel in manufacturing and technical work teams that support Production to identify root cause of a problem and determine appropriate corrective action for investigations.
- Consult with a range of internal, external and collateral contacts to correct non-routine and, or comprehensive issues, identify trends and determine corrective actions. Make recommendations that meet multiple technical, regulatory and business requirements.
- Review and approve protocols, validation documents and procedures, both internally and externally.
- Resolve unique and/or adverse situations, gather and review information from diverse functional areas, and make appropriate quality recommendations based on evidence.
- Provide leadership and technical expertise in conducting investigations and making recommendations for targeted data and information collection as required for quality events. Contributes to data and information collection.
- Act as technical resource with the FDA and other government agencies during site inspections.
- Alert management of critical issues that have significant impact to manufacturing objectives and timelines, while providing a range of achievable solutions.
- Approve change controls and support Change Control Board meetings as required.
- Represent QA in a range of team meetings, processes and initiatives both internally and at CMOs.
- Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.
- Actively demonstrates the values of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety and teamwork.
- Remain current and apply knowledge of FDA CFR 210/211 and other regulatory standards and guidance in the pharmaceutical industry
- * In the case of absence the reports to Manager above or a peer incumbent will function as a backup for this position.
Basic Qualifications
- BS/BA degree in a scientific discipline with minimum 5 years of progressive experience in the pharmaceutical or radiopharmaceutical industry or related GMP environment, or equivalent.
Other Requirements
- Aseptic fill-finish experience, including familiarity with validation of aseptic manufacturing technologies and facilities is preferred.
