Associate Specialist, Quality Control

Job Description

The Specialist in the Vaccine Biological Critical Reagents (BCR) group will be responsible for supporting the vaccines BCR programs. This position will perform hands-on work in warehousing, distribution and inventory management for biological critical reagents, such as reference standards, positive controls, and other critical materials. Under limited guidance, the incumbent will independently support the entire lifecycle of BCRs, from generation and testing to inventory and shipping. All work will be conducted to the highest quality and conform to GMP and regulatory expectations.

Primary Responsibilities include, but are not limited to:

The Specialist in the Vaccine BCR group will be responsible for supporting Critical Reagent programs in a fast-paced environment within the vaccines franchise. The performance of the critical reagents used in release and stability testing within the Quality Control Laboratories is important for release of vaccines products. Under the guidance of an AD, the Senior Specialist is responsible for independently managing the complete lifecycle of critical reagents, including reference standards, positive controls, anti-sera and other critical materials. The BCR lifecycle includes acquisition, certification and qualification testing, implementation, sample and inventory management, and ongoing monitoring and replacement of the material as required per established procedures. Additionally, the individual will demonstrate leadership in the implementation, execution and management of BCRs, and ensure work is conducted to the highest quality, and conforms to current Good Manufacturing Practices and regulatory expectations. The individual will also facilitate trainings and frequently share information to transfer technical and scientific knowledge to other members of BCR.

The Specialist, Quality Control, Vaccine BCR will be responsible for:

• Facilitating Work Teams in functional areas to include Receiving, Storing, Picking, Packing and Shipping
• Inventory Management and Recordkeeping for BCR Quality and Distribution Operations.
• Perform BCR GLIMS Transactions: record transactions in a timely manner, new material entry, item code generation, lot number entry, physical material movements, systematic movements, remove expired material, update expiry dates.
• Monitoring and protecting our company's assets and assuring that they are being properly controlled and effectively utilized to meet customer needs while maintaining a safe, secure, clean and high quality operating area.
• Support the coordination of shipments/export of critical reagenats to: West Point, domestic and international facilities.
• Ensure safe and compliant adherence with GMPs and all other regulatory requirements and standard business processes in shipping and exporting operations. Strong candidates will have experience in GMP, OSHA
• Develop and disseminate IMS expertise in inventory managment, small parcel and shipping processes. Strong candidates will have IMS, MH, and D&L experience.
• Collaborate closely with site and above-site customers and stakeholders to ensure success in all value streams.
• Primary contact for all BCR equipment, refrigerators, and freezers.
• Monthly GMP audits
• Monthly safety inspection
• eLog and Temperature monitoring, as needed.

Education Minimum Requirement:

• Bachelor's degree in Logistics, Business, Engineering, Science, Industrial Management, or other related areas of study.

Required Experience and Skills:

• 1-3 years of GMP laboratory, sample management, or quality control experience.
• Inventory management, warehousing and distribution
• Excellent communication skills (both written and oral)
• Demonstrated leadership and teamwork skills
• Ability to work independently
• Strong technical knowledge and high level of technical performance
• Ability to work effectively in a collaborative team environment
• General understanding of international and domestic biological material movement regulations.
• Understanding and historical application of how the sample management and logistics process support both analytical and process-based activities within commercialization
• Assure trade compliance with global and site regulations as applies to all processes, sites and resources within BCR
• Contribute to maintaining and implementing trade compliance Standard Business Procedures, tools, systems, and training to ensure compliance and to ensure the appropriate processes are properly incorporated into BCR
• Partner with area SMEs inside and outside of BCR on cross-functional initiatives, as appropriate.
• Lifting up to 40lbs
• Valid license, operate vehicle
• Additional Duties as assigned.

Required Skills:
Accountability, Accountability, Aseptic Manufacturing, Business Processes, Compound Management, Data Analysis, FDA Regulations, GMP Compliance, Good Laboratory Practices (GLPs), Import Export Management, Inventory Management, IS Audit, Keen Observation, Laboratory Instrumentation, Laboratory Operations, Laboratory Safety Protocols, Leadership, Logistics Management, Program Implementation, QC Microbiology, Quality Control Management, Reagent Preparation, Recordkeeping, Regulatory Requirements, Sample Management {+ 5 more}

Preferred Skills:

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.

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:

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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".

The salary range for this role is
$65,100.00 - $102,500.00

This 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 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:
No Travel Required

Flexible Work Arrangements:
Hybrid

Shift:
1st - Day

Valid Driving License:
Yes

Hazardous Material(s):
N/A

Job Posting End Date:
02/6/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the 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:R382036