Mantell Associates
Senior Quality Assurance Specialist
Mantell Associates, California, Missouri, United States, 65018
Direct message the job poster from Mantell Associates
Mantell Associates is partnered with a fast‑growing, innovation‑driven CDMO specialising in drug product development, who is searching for an experienced Senior QA Specialist – Supplier Audits.
This role is instrumental in strengthening supplier quality and compliance across a network of critical raw materials and component providers. Reporting to the QA Manager, you will be a key contributor to the Quality organization, responsible for leading supplier evaluations, audits, risk assessments, and ongoing supplier performance monitoring.
Senior QA Specialist – Responsibilities
Plan, execute, and lead supplier audits (on‑site and remote) in accordance with cGMP, ISO standards, and internal procedures.
Evaluate supplier quality systems, processes, corrective actions, and risk controls to ensure compliance and robust supply continuity.
Prepare comprehensive audit reports, findings, and recommendations, and drive closure of audit observations with stakeholders.
Support supplier qualification activities, including documentation review, risk assessments, and technical evaluations.
Collaborate with Quality, Procurement, Regulatory, and Manufacturing teams to escalate supplier risks and implement mitigation strategies.
Maintain audit schedules, quality intelligence, and supplier performance metrics to support continuous improvement.
Serve as a subject‑matter expert on supplier quality expectations, training internal partners as needed.
Senior QA Specialist – Requirements
Bachelor’s degree in Life Sciences, Engineering, Chemistry, or related discipline. Advanced degree or quality certification (e.g., ASQ CQA) preferred.
Significant experience in supplier quality, audits, and quality systems within a pharmaceutical, biopharmaceutical, or CDMO environment.
Strong knowledge of cGMP, ICH, regulatory expectations, and quality risk management principles.
Demonstrated ability to lead supplier audits and effectively communicate findings to technical and operational stakeholders.
Excellent analytical, report writing, and interpersonal skills with a proactive, solutions‑oriented mindset.
Ability to travel as required to support supplier audit activities (domestic and, occasionally, international).
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.
Referrals increase your chances of interviewing at Mantell Associates by 2x.
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Mantell Associates is partnered with a fast‑growing, innovation‑driven CDMO specialising in drug product development, who is searching for an experienced Senior QA Specialist – Supplier Audits.
This role is instrumental in strengthening supplier quality and compliance across a network of critical raw materials and component providers. Reporting to the QA Manager, you will be a key contributor to the Quality organization, responsible for leading supplier evaluations, audits, risk assessments, and ongoing supplier performance monitoring.
Senior QA Specialist – Responsibilities
Plan, execute, and lead supplier audits (on‑site and remote) in accordance with cGMP, ISO standards, and internal procedures.
Evaluate supplier quality systems, processes, corrective actions, and risk controls to ensure compliance and robust supply continuity.
Prepare comprehensive audit reports, findings, and recommendations, and drive closure of audit observations with stakeholders.
Support supplier qualification activities, including documentation review, risk assessments, and technical evaluations.
Collaborate with Quality, Procurement, Regulatory, and Manufacturing teams to escalate supplier risks and implement mitigation strategies.
Maintain audit schedules, quality intelligence, and supplier performance metrics to support continuous improvement.
Serve as a subject‑matter expert on supplier quality expectations, training internal partners as needed.
Senior QA Specialist – Requirements
Bachelor’s degree in Life Sciences, Engineering, Chemistry, or related discipline. Advanced degree or quality certification (e.g., ASQ CQA) preferred.
Significant experience in supplier quality, audits, and quality systems within a pharmaceutical, biopharmaceutical, or CDMO environment.
Strong knowledge of cGMP, ICH, regulatory expectations, and quality risk management principles.
Demonstrated ability to lead supplier audits and effectively communicate findings to technical and operational stakeholders.
Excellent analytical, report writing, and interpersonal skills with a proactive, solutions‑oriented mindset.
Ability to travel as required to support supplier audit activities (domestic and, occasionally, international).
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.
Referrals increase your chances of interviewing at Mantell Associates by 2x.
#J-18808-Ljbffr