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 laboratories.

• The Manager or Coach ensures that all compliance regulations cGMPs and internal guidelines are adhered to and/or enhanced.

• 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 needs.

• Responsible for knowledge of cGMPs and laboratory safety as well as the transfer of that knowledge to employees. 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:

Preferred Skills:

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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 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

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 employees 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 can apply for this role through (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

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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:

Relocation:

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