Quality Assurance Supervisor

Singota Solutions

20h•Onsite

About The Position

The Quality Assurance Supervisor provides oversight, assistance and guidance in daily quality activities associated with Operations oversight. This encompasses both Manufacturing (sample/dispense, aseptic filling and labeling/packing) and Supply Chain (receiving, storage, shipment) operations. This position also must positively interface with internal key stakeholders, clients and regulatory agencies regarding quality and regulatory issues pertaining to the business unit. 1. Responsible for supporting oversight of quality operations with Manufacturing and Supply Chain Management activities, including the review and approval of records and disposition of materials, as applicable. 2. Perform and/or oversee quality inspections including, but not limited to: labels, components, filled vials, and packaging. 3. Assist in managing Acceptable Quality Limit (AQL) sampling on products and materials in accordance with applicable protocols. Maintain visual inspection qualification. 4. Assist in the review and approval of executed operations supporting documentation, including but not limited to, sampling, dispensing, shipping, and receiving documentation, as applicable. 5. Participate in in-process reviews of manufacturing batch records and protocols. 6. Collaborate internally as well as with applicable suppliers to provide oversight for shipping qualification studies. Oversight includes review and approval of supplier provided protocols and reports. 7. Assist in maintaining material control via electronic inventory management system for materials, goods, and/or finishing product(s), in accordance with defined procedural controls, as applicable. 8. Serve as Subject Matter Expert (SME) on quality aspects of Manufacturing and Supply Chain processes. 9. Become gowning qualified to perform Quality functions within the cleanrooms (line clearances, batch execution support). 10. Author complex deviations, CAPAs, and change controls. 11. Write and review Standard Operating Procedures related to Quality systems within Supply Chain Management and Manufacturing. 12. Perform standard supervisory duties, such as mentoring employees, drafting and delivering performance reviews, delivering disciplinary actions, employee training, creating job descriptions and participating in the hiring process. 13. Responsible for utilizing sound judgement to make decisions regarding complex atypical events. 14. Participate in the development and maintenance of the site’s continuous improvement activities. 15. Perform other duties as assigned by the QA Manager. Perform all responsibilities in accordance with company guidelines and Standard Operating Procedures and appropriate industry and regulatory standards and guidelines. 16. Manage the scheduling/resource allocation for QA operations support. 17. Assist with license compliance 18. Comply with quality and safety management systems including requirements for documentation, training, system use, SOPs, processes, and procedures. 19. Provide support and oversight, as applicable, in the management of manufacturing materials specifications.

Requirements

Bachelor’s degree or equivalent experience – science-related field preferred.
Minimum of 10+ years pharmaceutical experience, preferably in a Quality role.
Previous supervisory experience and decision-making experience is desired.

Nice To Haves

Quality certifications (ASQ Quality Auditor, Lean Six Sigma, etc.) are highly desirable

Responsibilities

Responsible for supporting oversight of quality operations with Manufacturing and Supply Chain Management activities, including the review and approval of records and disposition of materials, as applicable.
Perform and/or oversee quality inspections including, but not limited to: labels, components, filled vials, and packaging.
Assist in managing Acceptable Quality Limit (AQL) sampling on products and materials in accordance with applicable protocols. Maintain visual inspection qualification.
Assist in the review and approval of executed operations supporting documentation, including but not limited to, sampling, dispensing, shipping, and receiving documentation, as applicable.
Participate in in-process reviews of manufacturing batch records and protocols.
Collaborate internally as well as with applicable suppliers to provide oversight for shipping qualification studies. Oversight includes review and approval of supplier provided protocols and reports.
Assist in maintaining material control via electronic inventory management system for materials, goods, and/or finishing product(s), in accordance with defined procedural controls, as applicable.
Serve as Subject Matter Expert (SME) on quality aspects of Manufacturing and Supply Chain processes.
Become gowning qualified to perform Quality functions within the cleanrooms (line clearances, batch execution support).
Author complex deviations, CAPAs, and change controls.
Write and review Standard Operating Procedures related to Quality systems within Supply Chain Management and Manufacturing.
Perform standard supervisory duties, such as mentoring employees, drafting and delivering performance reviews, delivering disciplinary actions, employee training, creating job descriptions and participating in the hiring process.
Responsible for utilizing sound judgement to make decisions regarding complex atypical events.
Participate in the development and maintenance of the site’s continuous improvement activities.
Perform other duties as assigned by the QA Manager. Perform all responsibilities in accordance with company guidelines and Standard Operating Procedures and appropriate industry and regulatory standards and guidelines.
Manage the scheduling/resource allocation for QA operations support.
Assist with license compliance
Comply with quality and safety management systems including requirements for documentation, training, system use, SOPs, processes, and procedures.
Provide support and oversight, as applicable, in the management of manufacturing materials specifications.