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Mgr, Quality Control- Stability

Merck
Full-time
Remote friendly (Lansdale, Pennsylvania, United States)
Worldwide
Operations
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Job Description

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Under direction of the Associate Director, the Laboratory Operations Manager- West Point Stability is responsible for oversight of the building and activities supporting the West Point stability program, including sample receipt from manufacturing areas, sample dispensing, sample preparation for entry into the stability program, sample shipping, sample storage, and compliant handling of all associated documentation.

The Stability Manager Will Perform The Following

  • Supervise hourly employees performing stability sample receipt, processing, and dispensing tasks
  • Schedule work based on priorities and business need
  • Administer local bargaining agreement and company personnel policies
  • Ensure compliance with OSHA requirements and company safety procedures
  • Promote teamwork and open communication
  • Act as a liaison between clerks and support groups to represent needs of the laboratory
  • Update SOPs, eLogs and other GMP documentation as required
  • Represent the laboratory in various Safety and Compliance initiatives, including safety inspections, permanent inspection readiness activities, and regulatory inspection
  • Maintain adequate inventory of supplies
  • Support deviation investigations, out-of-trend results, and test failures associated with product manufacture, release testing, and stability testing
  • Train Lab Operations Managers and Technicians
  • Self-identify and facilitate continuous improvement initiatives and special projects
  • Support in management of B70, including entering Work Orders, monitoring CTUs, driving building updates, and lead initiatives to maintain efficiency and compliance
  • Support and serve as backup for B70 Retention manager on an as needed basis

Education Minimum Requirement

B.S/B.A. or M.S in Microbiology, Biology, Virology, Biochemistry, or associated field

Required Experience And Skills

  • Minimum of (2) years’ post-degree laboratory, manufacturing, or quality control experience.
  • Working knowledge of GMPs
  • Strong communication, cross-functional collaboration, project management and analytical thinking skills
  • Demonstrated aptitude for continuous learning and analytical problem solving.
  • Ability to self-identify improvement opportunities and work autonomously where appropriate

Preferred Experience And Skills

  • Preferred experience in Audit and Inspections support
  • Preferred experience in Continuous Improvement and Lean Six Sigma Methodology
  • Preferred experience in team leadership/direct supervision of employees

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.

Requirements

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:

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

No Travel Required

Flexible Work Arrangements

Not Applicable

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

n/a

Job Posting End Date

05/8/2025

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:

R346907