Senior Specialist, Quality Assurance

Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured processed tested packaged stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant reliable supply to customers and patients on time every time across the globe.

Under the general direction of the Quality Assurance Integrated Process Team (IPT) Associate Director the Quality Assurance Senior Specialist is responsible for leading all quality assurance activities in support of the Integrated Process Teams (IPT) at the Wilson Site Packaging Center of Excellence for North America. The responsibilities of the Quality Assurance Senior Specialist include but are not limited to

• oversight of batch record reviews (audits) for domestic intermediate and finished product releases for domestic and/or international markets
• defect resolution in packaging operations and control of material throughout the plant
• plant investigations
• data compilation/ support for internal/external audits and regulatory inspections
• SOP development and review
• other Quality Assurance related functions as required.

The Quality Assurance Senior Specialist is the primary source of advice guidance and input regarding quality issues for production personnel divisional teams and inter-site addition this person is responsible for ensuring packaging activities are completed in compliance with all regulatory requirements cGMPs and corporate requirements through the coaching and development of other QA team personnel.

Additional responsibilities include but are not limited to:

• Quality Assurance functions for plant wide systems/processes to include direct line support to production areas deviations product release and defect resolution

• Attends cross-functional team meetings to ensure alignment of priorities and escalation of obstacles

• Quality Risk Management facilitation and expertise

• Manages activities to implement productivity enhancements to streamline activities

• Serves as final reviewer and Quality approver of deviation this capacity the Sr. Spclst ensures investigations have identified true root cause and appropriate corrective/preventative actions to prevent addition evaluates to ensure quality impact assessment is robust.

• Ensures Quality Assurance and overall site compliance in accordance with company policy and applicable government regulations. Makes provisions to ensure job responsibilities of the Quality Assurance area are conducted in a timely and reliable manner to meet productionsupply demands.

• Acts as a key regulatory compliance liaison to interface with domestic and international regulatory agencies during audits/inspections (CDER and CBER).

• Ensures that Quality Assurance maintains the necessary human and capital resources to meet present and future needs and manages those resources to meet annual profit plan.

• Ensures adequate Quality support / coverage during off-shift hours of operation

Education Minimum Requirement:

• Bachelors degree in a science discipline is required.

Required Experience and Skills:

• Five (5) years of experience in a GMP pharmaceutical manufacturing facility either with direct involvement in Quality functions supporting release and compliance activities or indirect involvement in Quality functions through execution of activities such as batch record/documentation reviews investigations corrective actions complaints quality system management etc.

• Deep understanding of Root Cause Analysis methods and investigation techniques.

• The candidate must possess highly developed written and oral communication leadership and teamwork skills.

• The candidate must also possess a high degree of problem-solving ability and have demonstrated ability to independently manage multiple high-level priority projects/workload ensuring timely completion.

Preferred Experience and Skills:

• Experience in Quality Assurance.

• Experience working in a Pharmaceutical packaging facility.

• Experience with regulatory inspections/audits (CDER and CBER).

• In-depth knowledge of domestic and international regulatory requirements.

• Experience designing and implementing lean business processes.

• SAP and MES system experience.

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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 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 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

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 can apply for this role through (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 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

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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.

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