Sr. Spclst, Quality Control-Micro Lead

Job Description

Key Responsibilities

• Project Management

• • Plan, schedule, and oversee microbiology-related project activities, ensuring scope, timelines, and quality objectives are met in a GMP environment.

  • Develop and maintain project plans, risk registers, action logs, and status reports; escalate risks and implement mitigation strategies.

  • Coordinate cross-functional inputs (QC Micro, QA, Manufacturing, Validation, Supply Chain) to ensure readiness and on-time execution.

• Laboratory Methods and Operations

• • Support and oversee testing activities for drug products and related materials, including endotoxin (e.g., LAL-based methods), sterility testing (per pharmacopeial requirements), and bioburden assessments.

  • Ensure adherence to validated methods, SOPs, and data integrity principles (ALCOA+) in routine and non-routine testing.

  • Partner with lab supervisors to allocate resources, prioritize sample testing, and remove operational roadblocks.

• Investigation and Problem-Solving

• • Lead or support laboratory investigations (e.g., OOS/OOT/Deviations), root cause analyses, and CAPA development; connect data trends and process inputs to identify systemic issues.

  • Drive continuous improvement initiatives to enhance testing efficiency, method robustness, and compliance.

• GMP Compliance and Documentation

• • Ensure all activities comply with GMP, relevant pharmacopeias (USP/EP/JP), and internal quality systems.

  • Produce high-quality English documentation, including protocols, reports, risk assessments, meeting minutes, and change control records.

  • Support audit readiness and participate in internal and external inspections as needed.

• Team Leadership and Communication

• • Lead effective team meetings with clear agendas, decision logs, and follow-up action tracking.

  • Foster a collaborative, accountable culture; mentor team members on best practices and procedural compliance.

  • Communicate project status, risks, and decisions to stakeholders and leadership in a clear, concise manner.

 

 

Qualifications

• Education: Master’s degree in Microbiology, Biology, Biotechnology, Pharmaceutical Sciences, or related field.

• Experience:

• • 3–7 years of experience in a GMP-regulated QC Microbiology or pharmaceutical environment.

  • Demonstrated project management experience coordinating laboratory or manufacturing-related projects.

  • Hands-on familiarity with microbiological test methods for drug products and/or Biological drug substance: endotoxin, sterility testing, bioburden, and related environmental monitoring practices.

• Skills:

• • Strong coordination, prioritization, and investigative skills with a track record of effective root cause analysis and CAPA implementation.

  • Excellent English documentation skills (protocols, reports, minutes); strong attention to detail and data integrity.

  • Proficiency with standard quality systems (SOPs, deviations, change controls) and basic statistics for trend analysis.

  • Ability to lead meetings, drive decisions, and influence without authority across cross-functional teams.

  • Proven team player with strong interpersonal communication and the ability to “connect the dots” across data, processes, and stakeholders.

  • Familiarity with project management tools (e.g., MS Project, Smartsheet) and collaboration platforms (e.g., Teams, SharePoint).

 

Preferred Qualifications

• Certification: Project Management Professional (PMP) or equivalent is a plus.

• Experience with rapid microbiological methods, data visualization tools, and electronic quality systems (QMS/LIMS).

• Knowledge of global regulatory requirements (FDA, EMA) and pharmacopeial standards (USP <85>, <71>, <61>/<62>).

 

 

Key Competencies

• Ownership and accountability

• Critical thinking and problem-solving

• Collaboration and influencing

• Communication and documentation excellence

• Compliance mindset and attention to detail

Required Skills:

Accountability, Accountability, Adaptability, Analytical Instrumentation, Analytical Method Development, Decision Making, Detail-Oriented, Environmental Monitoring, Environmental Monitoring Systems, Forensic Chemistry, GMP Compliance, Good Manufacturing Practices (GMP), IS Audit, Laboratory Information Management System (LIMS), Laboratory Operations, Microbiology, Molecular Microbiology, Pharmaceutical Sciences, Pharmacology, Project Management, Project Planning, Quality Control Management, Quality Management, Quality Objectives, Quality Standards {+ 5 more}

Preferred Skills:

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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:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

02/12/2026

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