Sr. Spclst, Quality Assurance

Merck; Durham (NC); On-site; USD 85,000 - 120,000; Full time

Job summary

Merck is seeking a Senior Quality Assurance Specialist for its Durham Site to enhance product release and ensure adherence to quality standards. The ideal candidate holds a bachelor’s degree in a relevant field with substantial experience in biotech/pharmaceutical manufacturing. Responsibilities include supporting batch releases, maintaining compliance with cGMPs, and leading quality initiatives. This full-time role operates under a hybrid work environment. Candidates will join a team dedicated to continuous improvement and excellence in quality assurance within a leading pharmaceutical company.

Qualifications

• Minimum of four years experience supporting the Biotech/pharmaceutical manufacturing industry.
• Ability to manage multiple high-priority projects.
• Knowledge of domestic and international regulatory requirements.

Responsibilities

• Support the site’s goals concerning batch release and quality requirements.
• Create batch-specific documentation and assist in regulatory audits.
• Lead process improvements and manage change control release tasks.

Skills

cGMP Regulations

Quality Assurance (QA)

Regulatory Compliance

Problem-Solving

Batch Releases

Education

Bachelor’s degree in Biology, Biochemistry, Chemistry, Engineering

Tools

SAP

MRP/ERP systems

GLIMS

Job description

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Primary Responsibilities:

Support The Company-Durham Site And Quality Organization By Performing Tasks Associated With The Site’s Goals And Initiatives As They Relate To Batch Release And Quality Requirements And Standards. This Involves The Items As Listed Below, But Is Not Limited To The Following:

• Product release of batches for a company-Durham Facility.
• Completion of tasks required to release batches such as DOM/SLED Review, QN and CR review, testing review, market restrictions review, and CBER submissions.
• Create batch specific documentation such as Health Authority monitoring reports or release-specific shipping documents, and prepare packaging or distribution requested batch certificates.
• Interface with technical, other quality tiers, release personnel, planning, warehouse, QPs, and problem-solving collaborative meeting groups to support release on time release group needs.
• Author, review, and approve local release SOPs, assist with providing product related information to support Change Requests, and complete change control release tasks.
• Serve as release SME (Subject Matter Expert) to support internal and regulatory audits.
• Support and lead department related initiatives associated with KPIs (Key Performance Indicators), process improvements, and other goal-driven directives— own project management opportunities, by leading and participating in process improvement, learning events, and/or business support initiatives, as guided or approved by Quality management.
• Consults on an as-needed basis with next-level manager on more complex release decisions and/or issues that impact other units with inter-related processes.
• Other duties as requested by Management.

Minimum Education Requirement And Experience:

• Bachelor’s degree (BA/BS) in Biology, Biochemistry, Chemistry, Engineering or other relevant discipline with a minimum of four (4) years experience supporting the Biotech/pharmaceutical manufacturing industry, specifically in operations, technical operations, validation and/or process Quality Assurance.

Required Experience And Skills:

• Ability to quickly learn new digital systems and software versions.
• Has in-depth knowledge of cGMPs and domestic and international regulatory requirements.
• A high degree of problem-solving ability.
• Demonstrated ability to independently manage multiple high level/ priority projects, ensuring timely completion.

Preferred Experience And Skills:

• cGMP experience with sterile, bulk or finished pharmaceutical/biotech manufacturing environments.
• Experience with release or disposition of Product, Raw Materials, and Components Release.
• Experience that include a variety of deviation/complaints, change control, release, regulatory, document control, master data management, laboratory, or manufacturing oversight experience. Not just one area.
• Experience with SAP, MRP/ERP systems and/or GLIMS.
• Flexibility to support on-call off shift and hyper-care related activities.

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Current Contingent Workers apply HERE

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”.

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: Hybrid

Shift: 1st - Day

Valid Driving License: No

Hazardous Material(s): N/A

Required Skills: Adaptability, Batch Record Review, Batch Releases, Biological Sciences, Business Initiatives, cGMP Regulations, Change Management, Chemical Biology, Deviation Management, Good Automated Manufacturing Practice (GAMP), Immunochemistry, Management Process, Manufacturing Environments, Manufacturing Quality Control, Pharmaceutical Manufacturing, Pharmaceutical Quality Assurance, Process Improvements, Product Disposition, Production Operations, Quality Assurance (QA), Quality Auditing, Quality Management Standards, Quality Standards, Regulatory Compliance {+ 5 more}

Preferred Skills:

Job Posting End Date: 06/3/2025

Requisition ID: R351115

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Quality Assurance

Industries

Pharmaceutical Manufacturing, Chemical Manufacturing, and Food and Beverage Services

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