Quality Assurance Senior Associate

Quality Assurance Senior Associate

3 Key Consulting is hiring a Quality Assurance Senior Associate for a consulting engagement with our direct client, a leading global biopharmaceutical company.

This role supports Quality Assurance department under the Operations organization providing daily oversight of Drug Substance Manufacturing production activities. Under general supervision, the role provides support and compliance oversight to Manufacturing, Facilities, Engineering, Supply Chain, and other support staff in the execution of their processes, procedures, and use of quality systems.

Duties include electronic batch record review, documentation review, SOP and Manufacturing Procedure revision, approval, work order approval, and quality approval of Deviations/Nonconformances and CAPAs. The candidate will be required to evaluate compliance issues, provide recommendations, and assure progress to completion. The candidate will also represent functional area quality for the Bulk Quality Assurance department in the execution of projects necessary to achieve departmental operational excellence goals. Candidates must have the ability to work in a team matrix environment and independently interact with various levels to drive items to completion.

Schedule will need to be flexible to support 24/7 operations. This includes days, swings, and night shifts.

Top Must Have Skills:

• Quality Mindset & Experience.
• Decision Making.
• Flexibility.

Day to Day Responsibilities:

Duties include electronic batch record review, documentation review, SOP and Manufacturing Procedure revision, approval, work order approval, and quality approval of Deviations/Nonconformances and CAPAs. The candidate will be required to evaluate compliance issues, provide recommendations, and assure progress to completion. The candidate will also represent functional area quality for the Bulk Quality Assurance department in the execution of projects necessary to achieve departmental operational excellence goals. Candidates must have the ability to work in a team matrix environment and independently interact with various levels to drive items to completion.

Employee Value Proposition:

Gain new hands-on work experience, and likely to get extended by the hiring manager.

Red Flags:

No Plant QA Experienced.

Interview process:

Video Skype Panel Interview