Specialist Quality Sytems and Compliance Position Available In Durham, North Carolina

Job DescriptionSpecialist, Quality Systems and Compliance Primary Responsibilities:

Support the 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 the Vaccine Manufacturing Facility .Support internal and regulatory audits.

Support 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.

Assist with providing product related information to support Change Requests (CRs).Author, review, and approve SOPs.

Train employees on new or revised processes or procedures.

Consults on an as-needed basis with next-level manager from a release perspective on more complex 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 two (2) years experience supporting the Biotech/pharmaceutical manufacturing industry, specifically in operations, technical operations, validation and/or process Quality Assurance.

Required Experience and Skills:

Has knowledge of cGMPs.

Is expected to possess a high degree of problem-solving ability.

Must have demonstrated ability to independently manage multiple high level/ priority projects, ensuring timely completion.

Preferred Experience and Skills:

Experience with electronic Batch Records (MES/PAS-X)cGMP experience in a sterile, bulk or finished pharmaceutical/biotech environment.

Experience with release or disposition of Product, Raw Materials, and Components ReleaseExperience with

SAP, MRP/ERP

systems and/or GLIMSFlexibility to support on-call off shift and hyper-care related activities. #EBRG VETJOBSCurrent Employees apply HERECurrent Contingent Workers apply

HEREUS 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:

EEOC Know Your Rights

EEOC GINA

SupplementWe 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 ActsU.S. Hybrid Work ModelEffective 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$85,600.00 – $134,800.00This 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 OrdinanceLos 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 OrdinanceSearch Firm Representatives Please Read CarefullyMerck & 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:

RegularRelocation:

No relocation

VISA Sponsorship:

NoTravel Requirements:

10%

Flexible Work Arrangements:

HybridShift:

1st –

DayValid Driving License:

NoHazardous Material(s):

N/ARequired Skills:

Aseptic Manufacturing, Biological Sciences, Corrective Action Management, Data Analysis, Documentations, FDA Compliance, Good Manufacturing Practices (GMP), Key Performance Indicators (KPI),

Performance Improvement Plans, Personal Initiative, Pharmaceutical Manufacturing, Policy Development, Problem Solving, Process Improvements, Production Operations, Quality Improvement Programs, Quality Standards, Regulatory Requirements, TeamworkPreferred Skills:

Job Posting End Date:

06/30/2025•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:

R354275PDN-9f3a7596-4d23-459c-96bf-ad736f3917fb