Manufacturing Services Associate Level I

Position Title: Manufacturing Services Associate Level I Work Location: Portsmouth NH 03801 Assignment Duration: 12 Months Work Schedule: 7:00 AM - 7:00 PM A shift; work week alternates between Monday, Tuesday, Friday, Saturday, Sunday and Wednesday, Thursday Work Arrangement: Onsite Position Summary: The Manufacturing Services Associate I is responsible for supporting all cGMP manufacturing production suites. They support the production groups by ensuring the suites are appropriately stocked with raw materials and consumables, assemble and autoclave assemblies for use, clean soiled parts, perform daily/weekly maintenance on analytical equipment, and complete scheduled cleaning requirements that are not fulfilled by the organization's contracted cleaning staff. They are expected to attain a basic understanding of cGMP compliance while training under close supervision, demonstrating aseptic technique and cross contamination awareness in handling of products and materials. Key Responsibilities: • Perform 6S and stock each suite daily, clean soiled parts daily. • Determine production needs for autoclaved assemblies and deliver to suites. • Perform daily and weekly maintenance activities on analytical equipment. • Perform weekly and monthly cleans of inoculum rooms. • Report all activities in written and electronic documents in accordance with good manufacturing practice (GMPs) and good documentation procedures (GDPs), review documentation as appropriate. • Attain qualification for all assigned tasks and maintain individual training plan. • Prepare materials for transport and delivery to manufacturing suites. Perform material movements into, out of, and across the production areas. • Maintain facility and equipment through routine cleaning and sanitization. • Administrative tasks – attending suite shift exchange, meetings, sending/receiving emails, participating in projects, perform other duties as assigned. • Perform other duties as assigned. Qualification & Experience: • High School Diploma or equivalent minimum (required). AS/BS in Science related discipline (preferred). • English – Native Speaker level (required). • Manufacturing or technical role – Entry Level – 0-4 years. • Strong written and verbal communication skills are required. • Mechanically inclined and able to put together parts per a provided procedure. • The employee is living the cultural beliefs with the flexibility to adapt to changing business priorities. • Is open to and actively seeks out feedback on their performance and translates that feedback into action. • Demonstrates an ability and desire to learn from experience. Treats errors as a learning opportunity. • Uses knowledge of his/her business area to make accurate and timely decisions. Understands the impact of his/her own actions on his/her business area. • Works as an active member of his/her team. Treats all co-workers and customers professionally and with respect. • Understands what internal and/or external customers need from him/her to deliver in his/her respective role. Takes action to enhance customer satisfaction within the scope of his/her role. • Demonstrates persistence and motivation to overcome obstacles and challenges. Ensures quality standards are maintained while delivering results. Plans, prioritizes and organizes work to deliver on time. • Takes responsibility for his/her safety and that of others. Takes responsibility for personal choices and behaviors. Seeks feedback and reflects on his/her development needs in order to continuously improve. Contributes to a positive work environment. Acts as a reliable and dependable member of the team. Working Conditions & Physical Demands (If Applicable): Work Schedule: Rotating Manufacturing Schedule (days or nights) Travel: <10% = low Safety: Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site. Quality Responsibility: Adherence to cGMPs is required at all times during the manufacture of APIs. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions. Environmental Demands: The normal working environment is: Production Floor Setting Physical Demands: Production related: Lifting 50lbs Mental Demands: Must have the ability to comprehend process flow and identify factors which influence the process. Must be able to read and follow defined SOPs and policies, work independently on basic manufacturing tasks, identify and communicate non-routine events, and review more complex decisions with Supervisors. Must be able to use automated process equipment and tools. Additional Information (If Applicable): Supervision Received: Close Supervision – The incumbent is assigned

Salary : $2,277 - $2,324