Job Description

Role Summary:

The Analytical Quality Assurance Specialist will provide QA oversight for analytical activities at contract manufacturing organizations (CMOs) & Contract Testing Laboratories (CTLs) supporting large molecule (biologics) manufacturing. This role ensures compliance with global regulatory requirements and internal quality standards, while collaborating closely with and CMOs & CTLs to maintain data integrity and product quality.

Key Responsibilities:

• Oversee analytical operations at CMOs and CTLs for large molecule drug substance and drug product manufacturing.
• Review and approve analytical method validation, transfer, and verification protocols/reports from external partners.
• Ensure compliance with GMP, ICH, WHO, and country-specific regulatory guidelines for biologics.
• Monitor and approve stability study protocols, data trending, and reports from CMOs/CTLs.
• Perform data integrity assessments for analytical instruments and electronic systems at partner sites.
• Support investigations, deviations, and CAPAs related to analytical activities at CMOs.
• Collaborate with internal teams and external partners to ensure timely resolution of analytical issues.
• Participate in audits and regulatory inspections at CMOs and CTLs, providing analytical QA support.
• Maintain change oversight for analytical methods and specifications across partner sites.
• Drive continuous improvement initiatives in analytical QA processes for outsourced operations.

Required Skills:

Adaptability, Adaptability, Analytical Validation, Biological Manufacturing, Change Management, Collaborative Development, Communication, Cross-Cultural Awareness, Cross-Functional Teamwork, Data Integrity, GMP Compliance, GMP Training, Good Distribution Practice (GDP), Inspection Readiness, Integrity Management, IS Audit, Leadership, Manufacturing Compliance, Manufacturing Quality Control, Pharmaceutical Quality Control (QC), Quality Assurance (QA) Standards, Quality Auditing, Quality Management Standards, Quality Metrics, Quality Standards {+ 4 more}

Preferred Skills:

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Secondary Language(s) Job Description:

Qualifications & Experience:

• Education: Master’s degree in Pharmaceutical Sciences, Chemistry, Biochemistry, or related field.
• Experience:
  • 15+ years in Quality Assurance or Quality Control in biologics/large molecule manufacturing.
  • Strong understanding of analytical techniques (HPLC, ELISA, PCR, etc.) and method validation principles.
  • Experience in contract manufacturing oversight and collaboration with external partners.
• Skills:
  • Excellent knowledge of GMP and data integrity principles.
  • Strong communication and stakeholder management skills.
  • Ability to manage multiple priorities and work in a fast-paced environment.

Preferred:

• Experience with monoclonal antibodies, vaccines, or other biologics.
• Exposure to electronic systems (LIMS, Empower, Digital applications implementations).

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

12/22/2025

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