Job Description

Position Overview:

This role provides an exciting opportunity to contribute to the operational excellence of our microbiology and sterility assurance laboratories. You will work closely with a dedicated team, drive quality improvements, and play a key role in ensuring compliance and robust laboratory practices. We are seeking a skilled Quality Control Specialist to join our team. This position will work directly with Laboratory Managers to ensure the safe, compliant, and efficient operation of our Quality Control microbiology and sterility assurance laboratories. As an individual contributor, you will support deviation management, problem-solving initiatives, and drive process and operational improvements to achieve and maintain operational excellence within the lab.

Key Responsibilities:

• Collaborate with Laboratory Managers to ensure adherence to safety, compliance, and operational protocols in the microbiology laboratories.

• Manage and support deviation investigations and CAPA (Corrective and Preventive Action) processes.

• Trend and analyze lab performance data to identify areas for improvement and implement solutions effectively.

• Conduct electronic log reviews to ensure regulatory compliance and accurate documentation.

• Lead key laboratory operations projects focused on enhancing compliance, assay robustness, and overall laboratory performance.

• Engage in continuous improvement initiatives to promote quality assurance and operational efficiencies.

• Provide direct support to microbiology laboratory operations, ensuring compliance with GMP (Good Manufacturing Practice) and other relevant regulations.

• Support the management team in day-to-day laboratory operations.

Education Minimum Requirement:

• Bachelor’s degree in Microbiology, Biology, Biochemistry, or a related field.

Required Experience and Skills:

• A minimum of 3 years of experience in a GMP manufacturing environment, particularly in Pharmaceutical or Biological Quality, Operational, Technical, or Regulatory functions supporting manufacturing or testing operations.

• Relevant laboratory experience in a regulated setting.

Preferred Experience and Skills:

• Direct experience working in a microbiological testing environment.

• Comprehensive understanding of general laboratory skills and aseptic techniques.

• Experience in project management and change execution within a quality-focused team.

• Strong interpersonal skills with a focus on collaboration, flexibility, and inclusion in team settings.

• Proactive and innovative problem-solving skills, demonstrating self-starter qualities.

• Analytical aptitude and critical thinking abilities with an emphasis on applying key concepts effectively.

• Strong written and verbal communication skills, with the ability to communicate with courage and candor.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

04/21/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.