Associate Specialist, Quality Control

MSD

7d•Hybrid

About The Position

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. 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.

Requirements

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

Nice To Haves

Strong candidates will have experience in GMP, OSHA
Strong candidates will have IMS, MH, and D&L experience.

Responsibilities

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.
Develop and disseminate IMS expertise in inventory managment, small parcel and shipping processes.
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.
Additional Duties as assigned.

Benefits

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.

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