Analytical Laboratory Metrology Specialist

Merck

Job Description

The Analytical Chemistry in Commercialization and Supply (ACDS) Operations and Compliance group has an exciting opportunity for Metrology Specialist positions at our Rahway, NJ and West Point, PA sites.

We are seeking highly talented and motivated individuals to serve in a metrology specialist role that is responsible for the oversight of regulated and non-regulated laboratory equipment in a fast-paced, multidisciplinary lab environment. The candidate will be involved in overseeing the lifecycle of the lab instrumentation covering acquisition and installation, performance or coordination of routine maintenance, computer system validation(SDLC), and regulated systems retirement.

Position responsibilities:

• Prepare, review, and approve instrument/equipment documentation such as master equipment lists, qualification documentation, and calibration documentation

• Coordinate service activities across a variety of vendors and service engineers while building and maintaining strong working relationships

• Gain a working knowledge of laboratory equipment to facilitate troubleshooting and/or perform maintenance or calibration activities

• Participate in computer system validation activities associated with new or upgraded equipment or software packages

• Support the purchase, installation and equipment qualification of new laboratory equipment

• Collaborate with metrology and partner groups to drive quality, data integrity and operational excellence as well as process improvements, training and site support

• Originate and progress deviation and Change Management (CM) records to document impact of instrument changes and issues

• Perform and document investigations and assist in developing/implementing CAPA plans

• Support internal and external audits, while maintaining labs in a state of permanent inspection readiness

• Work both independently and collaboratively in a fast-paced, integrated, multidisciplinary team environment and partner network

• Ensure compliance with all regulatory requirements (cGMP) and internal policies and procedures, with a strong focus on data integrity

Education Minimum Requirement:

• B.S. Degree in Chemistry, Engineering or closely related scientific field

Required Experience and Skills:

• Experience working within a regulated (GMP) laboratory and adherence to data integrity and compliance principals

• Familiarity with analytical laboratory equipment including HPLCs, GCs, UVs, dissolution systems, IR, Karl Fischer, and dissolution with ability to troubleshoot them

• Highly organized/strong attention to detail and capable of multi-tasking to manage a variety of laboratory equipment or system related schedules, documents, and maintenance tasks

• Technical and innovative problem-solving skills

• Capable of working both independently and within a cross-functional team to deliver complex objectives under aggressive timelines in a rapidly changing environment.

• Strong verbal and written communication skills with an eagerness to learn, adapt and improve subject matter expertise

• Strong interpersonal skills for interacting with a variety of on-site and off-site collaborators and partner groups

Preferred Experience and Skills:

• Experience with maintenance of analytical instrumentation with ability to troubleshoot them

• Experience with computerized standalone systems GMP validation requirements (SDLC)

• Familiarity with authoring relevant instrument standard operating procedures (SOPs)

• Experience in internal/external quality inspections and audits

• Experience with change management and deviation management

Required Skills:

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:

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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 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

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

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Requisition ID:R384477