Support Associate - Manufacturing

Workforce Opportunity Services (WOS) is a leading 501(c)(3) nonprofit committed to developing the skills of untapped talent from historically underrepresented communities through partnerships with organizations dedicated to diversifying their workforce.
We celebrate diversity and are committed to creating an inclusive environment for all employees and ensuring a workplace free from all forms of discrimination or harassment. We strongly encourage people of color, women, veterans, people who identify as LGBTQIA, and members of ethnic minorities to apply!
About the Opportunity
Merck and Co. has joined a coalition of leading executives and their companies who came together to upskill, hire and promote one million members of under-served communities over the next 10 years who do not have a four-year degree into family-sustaining jobs. Merck is currently searching for a Support Associate - Manufacturing to fill a role in Durham, NC.
The Support Associate maintains areas in compliance with GMPs and other applicable regulatory guidelines by performing all housekeeping, disinfection, and waste management of assigned production environments. Adheres to all company safety guidelines and procedures. Monitor facility conditions during activities defined above and perform general tasks to ensure the environment and equipment are maintained in full regulatory compliance. Tasks will include but are not limited to equipment cleaning and minor surface repairs using common hand tools.
Primary Responsibilities:

• Aligned with production activities, will assist others in removing used process equipment or assisting with the breakdown of equipment following completed operation
• Assists in the reviews of batch records
• Steam Sterilization activities using autoclaves and Distributive Control Systems
• Aligned with Biotechs, Management, or other Technical Personnel, assists with the production operations completing much of the general production steps with Biotech, Management, or other Technical Personnel oversight and review
• In compliance with manufacturing requirements, prepares and sterilizes growth media buffers and other solutions used in production processes
• Prepares and sterilizes process equipment and interfaces with Distributed Control System to control cleaning, sterilization, and manufacturing operations
• Using appropriate data management systems, manages and ensures inventory of all necessary production and support supplies
• Identifies and reports variances from specifications to supervisor or designate
• Reviews GMP logs and other applicable GMP documentation
• Depyrogenation activities using dry heat ovens and maintains equipment in good working order
• Follows written procedures and direction of Management or other Management
• Troubleshoots, and reports safety and maintenance concerns to area management or other designate
• Conducts environmental sampling and sample management
• Maintain appropriate GMP documentation for all responsible activities and compliance with training requirements
• Monitors operations and intervenes as necessary and communicates status to responsible personnel
• Assigned personnel and contributes to the identification and resolution of process or equipment problems
• Achieves and maintains job proficiency through continued training
• Supports management technical personnel as required with start-up activities including the validation of manufacturing facility, qualification lots and scale1up
• Initiates all tasks required to ensure a supply of sterile and/or cleaned equipment, including, but not limited to CIP of equipment using manual and automated equipment washers and wash systems
• Contributes to the creation and revision of Batch Records, Standard Operating Procedures, and other regulatory documents defined for production compliance
• Attends and actively participates in HAZOPS, waste walk through, Kaizen events, or any other operations, lean six-sigma, quality, safety or environmental training
• Assists in the operation of process equipment
• Orders, receives and stocks required components/supplies to operate progress

Qualifications:

• High School Diploma (or equivalent)

Job Type:

• Full-Time

Salary:

• $60,000 - $70,000/Annually (Depending on Experience)

Location:

• Durham, NC