Merck & Co Hiring for Specialist, Laboratory Quality Assurance job in West Point Full Time

Job Description

The Laboratory Specialist within the Quality Assurance Center of Excellence, with guidance from the Associate Director of Quality Assurance, provides Quality support to Laboratory Operations.- The Laboratory Specialist will review laboratory data to ensure that all laboratory data is maintained in accordance with prescribed specifications, procedures and Good Documentation Practices.- Data review will include the evaluation of raw data as well as verification of final data integrity (i.e., calculations, adherence to SOPs, BATs, BLPs, Compendia).- The Laboratory Specialist will also approve Master Laboratory worksheets prior to issuance to Laboratory Operations.

The Laboratory Specialist will represent quality on the shop floor and perform documentation accuracy and completeness checks while on the shop floor.- He or she will work closely- with- the- assigned- laboratory in- a- team- environment- to- ensure- timely- reviews of documentation and to ensure that documentation is completed right the first time.- The Laboratory Specialist will work with Laboratory Operations staff and management to remediate comments and errors in documentation.- He or she may also assist Laboratory Operations in conducting investigations associated with laboratory data review.- Additionally, the Laboratory Specialist will utilize time on the shop floor to provide Quality coaching and guidance to Laboratory Operations and technology personnel, to enable right first time testing and to ensure compliance with cGMPs and regulatory requirements.-

The Laboratory Specialist will also be trained to support Quality Assurance system functions and to support End to End Quality Operations as needed.

Responsibilities

• Present on shop floor to provide compliance support and to provide Quality coaching and guidance to Laboratory Operations and Technology personnel.
• Actively participate in the Tier process and use this forum to make concerns visible and to partner with Laboratory Operations on resolution.
• Responsible for the independent auditing of laboratory data in alignment with the policies of the department, division, company and other applicable mandates.- Maintain the highest level of proficiency in terms of those duties and responsibilities required of auditors.

• Maintain metrics and tracking associated with these documentation reviews.
• Complete the remediation activities for all data reviews, to ensure errors are appropriately corrected and documented following departmental and site procedures.

• Perform review and approval of qualification documents as needed.
• Ensure that laboratory data is in compliance with cGMPs, GLPs and departmental procedures and assay methods and is of the–
• highest integrity, quality and accuracy.
• Responsible for approval of Master Laboratory Worksheets prior to issuance to floor for use.
• Responsible for issuance of new and reconciliation of completed laboratory worksheets.
• Foster a customer service attitude within Laboratory Operations.
• Review laboratory notebooks, logbooks and CTU records to ensure accuracy and data integrity compliance.
• Assist with training of incoming personnel.
• Provide support to Regulatory Agency inspections as needed.

Minimum Required Education, Experience and Skills:

• Bachelor’s degree or higher, preferably in Life Science, scientific discipline with one (1) year of relevant experience in manufacturing engineering preferred OR M.S. degree in life science, scientific-discipline or engineering.
• Direct experience with documentation review and / or control, or prior experience supporting Regulatory Agency inspections is required.

OR

• High School Diploma/GED or Associates with six (6) years of relevant experience in manufacturing or military service.

•

Required Experience and-Skills

• Minimum one to two years of relevant post-degree work in-GMP Manufacturing-or Laboratory environment,-Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations,-or related industry experience in a laboratory, manufacturing, science related or regulated setting

Preferred Experience and Skills

• Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment.
• Demonstrated analytical aptitude, critical thinking skills and problem solving skills.
• Demonstrated ability to upskill / coach others.
• Strong written and verbal communication skills.
• Experience in pharmaceutical laboratory operations or related environment-

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NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers’ Policy – Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). -Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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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, generally Tuesday, Wednesday and either Monday or 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”.

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:
On-Site

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
n/a

Requisition ID:R272938