Job Description

Position Overview - Basic Functions & Responsibility

The Quality Specialist provides direct Quality support to a production areaas part of a Quality IPT (Integrated Product Team).With guidance from theBatch Record Review Quality Manager,the Quality Specialistensures quality, and compliance of products manufactured by the functional area, adherence to Good Manufacturing and Documentation Practices, and represents quality on the shop floor.The Quality Specialist performsreviewof processdocumentation/datafor accuracy,completeness,anddata integritycompliance.The incumbentmay support thecompletion ofbatch disposition activities for release of productandmay assist in conductinginvestigation of deviations. Additionally, the Quality Specialist spends significant time on the shop floorin a team environmenttoprovide quality coaching and guidance, to enabledocumentationto becompleted right the first time, and to ensure compliance withcGMPsand regulatory requirements.

Primary Activities:

• Becomes fully trained in relevant Standard Operating Procedures (SOPs), Work Instructions (WIs)and competency-based activities

• LearnscGMPs, the manufacturing process, and our company quality systems, including SAP, GLIMS and electronic logbook, laboratory data, and batch record platforms

• Provides presence on the shop floor to support complianceand data integrity.

• Reviews production documentation such as batch recordsandlogbooksto ensure accuracy and compliance withcGMPsand company proceduresand ensures completion ofproperremediationof errors

• Collaborates with cross-functional team members to ensure batches are ready for release by appropriate due dates and executes the appropriate quality checksand SAP transactionsrequired

• Responsible for routine auditing of GMP practices, documentation, and data

• Collaborates with cross-functional team members identifying and implementing continuous improvement initiatives and action plans

• Reviews and approves new and updated SOPs and Controlled Job Aids

• Actively participates in the Tier process andusesthis forum to make concerns visible and to partner with the functional area on resolution

• Responsible forreview/approvalof new and updated Master Batch Records

• Performs review/approval of Qualification documents as needed

• Cross trains to support other functional quality areas including deviation management,documentation review,environmental monitoring, and qualification activities

• Provides support to internal audits and regulatory inspections as needed

• Fosters a customer service attitude within the functional area

RequiredEducation:

• Bachelor's degree, in a scientific or engineering field (preferred); candidates with degrees in other fields will be considered if accompanied by significant relevant experience.

RequiredExperience andSkills:

• Minimum 1-2years of relevant post-degree work experience inGMP Manufacturingor 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.

• Evidence of leadership skills coupled with good oral and written communication skills.

• Understanding ofcGMPsand of regulatory requirements as they apply to the pharmaceutical field or a related area.

• Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment.

Preferred Experience and Skills:

• Experience in qualitysystems, pharmaceutical manufacturingor laboratoryprocesses, authoring and approving GMP documents.

• Experience withAseptic gowningmay be required.

• Demonstrated analytical aptitude, critical thinking skills andproblem-solvingskills.

• Demonstrated ability to upskill / coach others.

• Familiarity withGMPdocumentation review and/or shop floor auditing.

• Titers may be required.

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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas 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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe 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:R323684