Sr. Spclst, Quality Systems & Compliance
Sr. Spclst, Quality Systems & Compliance
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Job Description
Job Description
The Senior Specialist Quality serves as a member of a team responsible for instituting consistent practices across the Durham facility in the disciplines of Deviation Management Complaints Corrective Action/Preventive Action Management Annual Product Review Authoring and Quality Council.
The Senior Specialist Quality Assurance will be primarily responsible leading the Deviation and CAPA management systems. The role is responsible for leading the local community of practice and representing Durham in the global communities of practice associated with the indicated quality systems.
General Profile:
Monitor standard work within the assigned quality systems and implement improvements to adherence to compliance requirements
Direct support of regulatory inspections and audits including presentation/defense of Deviation and CAPA Management systems during regulatory inspections.
Metrics reporting and development in support of Quality Council
Lead site Community of Practice (CoP) providing relevant ongoing system updates and facilitate collection of feedback to share within the global CoP.
Make decisions guided by policies and procedures that impact the units ability to meet performance objectives
Influence stakeholders across various departments and levels fostering collaboration and alignment on quality initiatives
Support of site deviation management huddles as needed
Perform SOP development review and/or quality approval
Assist in Permanent Inspection Readiness projects
Other duties as assigned by Management.
Consults on an asneeded basis with nextlevel manager on more complex decisions and/or issues that impact other units with interrelated processes
Minimum Educational Requirement and Experience:
Bachelors degree (BA/BS) in Biology Biochemistry Chemistry Engineering or other relevant scientific discipline
Minimum of five (5) years experience supporting pharmaceutical manufacturing/quality management systems
Demonstrated ability to independently manage multiple priorities ensuring timely completion
Drives results escalation of issues / concerns to management as appropriate.
Preferred Experience and Skills:
Technical writing skills
Quality systems experience
Pharmaceutical vaccine manufacturing experience
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
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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 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 officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining 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 preexisting agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.
Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Applied Engineering Applied Engineering Aseptic Manufacturing Biochemistry Chemical Biology Collective Bargaining Complaint Management Compliance Reviews Consulting Corrective Action Management Driving Continuous Improvement EU GMP GMP Auditing GMP Compliance Immunoassays Immunochemistry Inspection Readiness Job Descriptions Master Batch Records Microbiology Organic Chemistry Pharmaceutical Manufacturing Pharmaceutical Systems Physiology Policy Compliance 14 morePreferred Skills:
Job Posting End Date:
05/27/2025*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.
Required Experience:
Senior IC
Employment Type
Full-Time
