Sr Associate QA

Sr Associate QA

3 Key Consulting is hiring a Sr Associate QA for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.

Job Details:

• 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 Skill Sets:

• Quality Mindset & Experience
• Decision Making
• Flexibility

Employee Value Proposition:

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

Red Flags:

No Plant QA Experience

Interview Process:

No more than 5 phone interviews to be conducted until 12/08.

We invite qualified candidates to send your resume to View email address on click.appcast.io. If you decide that you're not interested in pursuing this position, please feel free to look at other positions on our website You are welcome to also share this posting with anyone you think might be interested in applying for this role.