Comforcehealth
Associate Director, Quality Assurance Operations - Healthcare & Research - Analy
Comforcehealth, Bedford, Massachusetts, us, 01730
Associate Director, Quality Assurance Operations - Healthcare & Research
Job ID: 1007606 | Location: Bedford, MA | Contract – 3+ months
Job Description Associate Director, Quality Assurance Operations (Full-time, Contract). Duration: 3+ months. Location: Bedford, MA.
Responsibilities
Provide on-the-floor quality operations support across all areas and own the master batch record lifecycle, including final review and approval.
Provide technical quality guidance as part of teams conducting investigations for complex manufacturing events.
Review and approve complex deviations and/or investigations that are site specific.
Actively support and/or lead preparation activities for pre-approval inspections and/or responses to observations.
Work with product release teams to support issuance of drug substance certificates of conformance and any other disposition required activities.
Manage CAPA records and serve as CAPA manager for minor or major CAPAs as needed.
Serve as QA reviewer or impact assessor for downstream purification change control records.
Support and/or review various reports from quality systems.
Own various quality procedures and ensure the systems/processes are deployed effectively.
Qualifications
Excellent technical and regulatory understanding of downstream drug substance purification processes.
Strong experience with root cause analysis techniques (5‑why, Kepner‑Tregoe, force‑field analysis, DMAIC, fault tree analysis).
Capability of interpreting and adapting technical reports to support investigations/deviations.
Demonstrate concise and clear writing of investigation summaries.
Strong understanding of industry regulations (CFR, USP, EP, JP).
On‑floor biologics experience in a GMP environment required.
7+ years of leadership/management experience in an Operations, Manufacturing Technology or Technical Quality professional role.
BS/BA in Biological or Chemical Science preferred; 9+ years of relevant experience.
OR
Master’s Degree in Biological or Chemical Science; 8+ years of relevant experience.
Pay Range and Benefits Pay Range: $80.00–$90.00 per hour.
Benefits (eligible): Medical & pharmacy coverage, Dental/vision insurance, 401(k), HSA, FSA, Life Insurance, Pet Insurance, Short‑term and Long‑term Disability, Accident & Critical illness coverage, Pre‑paid legal & ID theft protection, Sick time, EAP.
About Innova Solutions Founded in 1998, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 B. Through global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients.
Contact Harish Yadav | Phone: 213‑797‑4030 | Email: harish.yadav@innovasolutions.com
Equal Opportunity Employer Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. We are committed to an inclusive work environment. If you need a reasonable accommodation, contact thra@innovasolutions.com or (770) 493‑5588.
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Job Description Associate Director, Quality Assurance Operations (Full-time, Contract). Duration: 3+ months. Location: Bedford, MA.
Responsibilities
Provide on-the-floor quality operations support across all areas and own the master batch record lifecycle, including final review and approval.
Provide technical quality guidance as part of teams conducting investigations for complex manufacturing events.
Review and approve complex deviations and/or investigations that are site specific.
Actively support and/or lead preparation activities for pre-approval inspections and/or responses to observations.
Work with product release teams to support issuance of drug substance certificates of conformance and any other disposition required activities.
Manage CAPA records and serve as CAPA manager for minor or major CAPAs as needed.
Serve as QA reviewer or impact assessor for downstream purification change control records.
Support and/or review various reports from quality systems.
Own various quality procedures and ensure the systems/processes are deployed effectively.
Qualifications
Excellent technical and regulatory understanding of downstream drug substance purification processes.
Strong experience with root cause analysis techniques (5‑why, Kepner‑Tregoe, force‑field analysis, DMAIC, fault tree analysis).
Capability of interpreting and adapting technical reports to support investigations/deviations.
Demonstrate concise and clear writing of investigation summaries.
Strong understanding of industry regulations (CFR, USP, EP, JP).
On‑floor biologics experience in a GMP environment required.
7+ years of leadership/management experience in an Operations, Manufacturing Technology or Technical Quality professional role.
BS/BA in Biological or Chemical Science preferred; 9+ years of relevant experience.
OR
Master’s Degree in Biological or Chemical Science; 8+ years of relevant experience.
Pay Range and Benefits Pay Range: $80.00–$90.00 per hour.
Benefits (eligible): Medical & pharmacy coverage, Dental/vision insurance, 401(k), HSA, FSA, Life Insurance, Pet Insurance, Short‑term and Long‑term Disability, Accident & Critical illness coverage, Pre‑paid legal & ID theft protection, Sick time, EAP.
About Innova Solutions Founded in 1998, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 B. Through global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients.
Contact Harish Yadav | Phone: 213‑797‑4030 | Email: harish.yadav@innovasolutions.com
Equal Opportunity Employer Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. We are committed to an inclusive work environment. If you need a reasonable accommodation, contact thra@innovasolutions.com or (770) 493‑5588.
#J-18808-Ljbffr