Quality Control Job at MSD | Apply Now for the Sr. Spclst Role
Merck (MSD) is inviting applications for a Sr. Spclst, to oversee critical microbiology project activities in a GMP environment. This Quality Control Job requires a Master’s degree and 3–7 years of experience in QC Microbiology, with a deep focus on sterility testing, endotoxin assessment (LAL), and bioburden. The lead will manage cross-functional teams, drive OOS/OOT investigations, and ensure that all laboratory operations adhere to ALCOA+ data integrity principles and global pharmacopeial standards (USP/EP/JP).
About The Company
Merck & Co., Inc., Rahway, NJ, USA (operating as MSD globally) is a premier biopharmaceutical leader that has spent over a century tackling the world’s most complex diseases. Importantly, this company provides many career paths for those seeking a job focused on quality control. The company is built on a foundation of “ownership and accountability,” fostering a collaborative culture where scientific excellence meets patient-focused innovation. Merck is renowned for its rigorous adherence to GMP and ALCOA+ data integrity standards, utilizing advanced systems like LIMS and electronic quality management to ensure the safety and efficacy of its global drug product portfolio.
Name of the Post: Sr. Spclst, Quality Control-Micro Lead
Location: Hyderabad, Telangana, India
Role Summary
As the QC Micro Lead, you act as the bridge between the laboratory and the broader supply chain. You are responsible for the strategic planning of microbiology projects, managing resource allocation for drug product testing, and ensuring every vial and batch complies with international pharmacopeial standards.
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 as part of your duties.
- 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. These are key tasks in any quality-focused control job.
- 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 for the quality control job requirements.
- 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, central to the expectations for this job.
- 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 for your quality control job responsibilities.
- 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 is highly valued by recruiters advertising quality control job roles.
Experience
- 3–7 years of experience in a GMP-regulated QC Microbiology or pharmaceutical environment will benefit you in a job in quality control.
- 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 is advantageous for those seeking a quality control job.
Skills
- Strong coordination, prioritization, and investigative skills with a track record of effective root cause analysis and CAPA implementation, all key assets for a job in quality control.
- Excellent English documentation skills (protocols, reports, minutes); strong attention to detail and data integrity, important for any quality control job position.
- 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, reflecting important attributes for a quality control job.
- Proven team player with strong interpersonal communication and the ability to “connect the dots” across data, processes, and stakeholders, often necessary in a quality control job.
- Familiarity with project management tools (e.g., MS Project, Smartsheet) and collaboration platforms (e.g., Teams, SharePoint) will further strengthen your qualifications for a job in quality control.
Preferred Qualifications
- Certification: Project Management Professional (PMP) or equivalent is a plus for advancing within a quality control job track.
- 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>) demonstrates preparedness for a Quality Control Job with international standards.
