We Hire America Jobs

Job Description

Our Quality Organization ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Under the direction of the Associate Director of Quality Control Laboratories, the QC Lab Manager is responsible for providing guidance and supervision to QC Specialists and Technicians to complete testing and testing support activities. Responsible for team development of experienced QC analysts, maintenance of a robust training program, and for facilitating a compliant and safe culture through policy deployment and application. This is a dynamic role in a fast-paced environment, with 12-15 direct reports.

Additional Responsibilities:

• Manage, coach and mentor QC team to build technical expertise among the group. Build diverse talent with the capabilities necessary to succeed. Promotes collaboration, teamwork, and open communication

• Responsible for testing of final and bulk product, raw materials, and is knowledgeable in the analytical techniques for the laboratory(s) they support.

• Authoring, Reviewing, Revising and approval of SOPs, Quality Control Procedures, and other business critical documentation.

• Oversees QC training program to ensure employees are competent and qualified to perform duties.

• Critically evaluating data generated for product release and recommending acceptance or rejection

• Maintain records, develop improvement plans, tracking functions such as corrective actions, special projects, etc.

• Leading and/or supporting Investigations, Root Cause Analysis, and CAPA implementation and effectiveness evaluations.

• Leading and/or supporting effective Change Control of processes and documentation.

• Investigating safety and environmental incidents and near misses. Model a safe and compliant culture throughout the laboratories.

• Support internal audits and regulatory lab inspections as a subject matter expert.

• Act as a resource and liaison between technicians and support groups to represent the needs of the laboratory.

• Initiate and follow-up on equipment repairs and follow-up on facility work orders for laboratory modifications.

• Required collaborating with Quality Assurance and Operations colleagues.

• Support hiring and onboarding of employees

Education Requirements:

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

Required Experience and Skills:

• Minimum five (5) years of post-degree laboratory, manufacturing, or quality experience in a regulated environment.

• Working knowledge in the biotech industry with specific understanding of QC operations, regulatory agency engagement and ability to gain alignment on strategy.

• Demonstrated principled verbal and written communications.

• Servant Leadership Mindset

• Excellent interpersonal communication skills

• Demonstrated ability or aptitude for continuous learning and analytical problem solving with experience in root cause analysis and CAPA deployment.

Preferred Experience and Skills:

• Experience developing and improving methods for biological and/or biochemical assays.

• Continuous Improvement and Lean methodology experience.

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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 (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)

EEOC GINA Supplement​

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas 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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

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:

04/14/2025

*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.

Requisition ID: R343338