Lab Release Coach

Job Description

POSITION OVERVIEW - Basic Functions & Responsibility

Essential functions include, but are not limited to:

• Under the general direction of the Director, Wilson Quality Control Laboratory Operations , the Manager is responsible for administration of NASU and Wilson l a b ora t or i es .
• The Manager or " Coac h " ensures that all compliance regulations, cGMPs, and internal guidelines are adhered to and/or enhan c ed .
• The Manager manages activities to implement productivity enhancements to streamline activities.
• The Manager executes activities to meet or exceed customer expectations through a staff of professionals at the B.S. , B.A., M . S., and Ph.D. levels.

PRIMARY ACTIVITIES

Primary activities include, but are not limited to:

• Drives continuous improvement and supports sustainability of implemented changes identified through such lean tools or champions new actions as a result of data obtained through lean methodology.
• Responsible for the necessary personnel and equipment resources to perform technical support, microbial testing, stability testing, release testing, supplies inspection, copy reading, API testing to ensure that customer expectations are met or exceeded .
• Aligns resources with business unit needs.
• Actively participates in Plant/Quality committees and works with other QO groups, Planning, Manufacturing, Packaging, Maintenance, and others as required to resolve problems, and satisfy quality and production n e eds .
• Responsible for knowledge of cGMP's, and laboratory safety, as well as the transfer of that knowledge to employee s . Routinely makes decisions using cGMP and safety knowledge as a guide.
• Edits, writes, and/or approves departmental SOPs and investigations .
• Acts as a key regulatory compliance liaison to interface with regulatory agencies during audits of assigned areas. Performs duties and responsibilities of the Director in his/her absence.
• Reports to the Quality Director for general advice and instruction, but normally handles routine matters independently, consulting on major problems only.
• Manages a staff of Associate Specialists, Senior Specialists, and others as needed
• Responsible for administrative and personnel actions such as hiring, transfers, training, salary and appraisal administration.
• Manages activities to identify and correct problems, emphasizing prompt and definitive resolution to minimize adverse impact and reoccurrence.
• Manages QC area in accordance with company policy and applicable government regulations . Makes provisions to assure job responsibilities of the QC area are conducted in a timely and reliable manner to meet production demands.
• Ensures that all contemporary policies (SOPs, QSs, SATs, Departmental Policies,) are maintained and adhered to within the laboratory . Participates in the generation and interpretation of divisional policies/guidelines.
• Supports initiatives that involve the necessary human and capital resources needed to meet present and future QC needs; and manages those resources to meet annual profit plan.
• Supports the achievement of plant objectives (e.g., metrics, productivity, etc.).
• Applies leadership principles to testing operations.
• Supports Laboratory Data Services team
• Performs other duties as assigned.

Education Requirements:

• B.A./B.S. degree (preferably in Science or Engineering)

Required Experience and Skills:

• Knowledge of continuous improvement principles
• Minimum of five (5) years of pharmaceutical industry experience
• Minimum of (3) years of Quality Control and / or Microbiology Lab experience

Preferred Experience and Skills:

• Root cause analysis
• Background in technical writing
• Experience with complex technical and/or analytical investigations and CAPA resolution
• Experience applying 5S concepts
• Experience with SAP, Data Integrity, cGMP, 21CFR requirements, laboratory analysis principles and execution, MIDAS, LIMS, equipment qualification, method transfer, change control, and stability principles
• Previous management experience

Required Skills:
Analytical Method Transfer, Analytical Testing, Analytical Thinking, cGMP Compliance, Corrective Action Management, Driving Continuous Improvement, GMP Documentation, Instrumentation, Laboratory Operations, People Leadership, Pharmaceutical Quality Control (QC), Quality Standards, Team Supervision, Technical Writing

Preferred Skills:

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

EEOC GINA Supplement

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".

The salary range for this role is
$94,300.00 - $148,500.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:
12/9/2025
*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:R373488