Operations Specialist - II (Associate)

TalentBurst; Rahway (NJ); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading company is seeking an Operations Specialist - II to support manufacturing and technical operations at their Rahway, NJ facility. The role involves collaboration with internal stakeholders, ensuring compliance with safety and quality standards, and leveraging scientific knowledge to resolve operational issues. Candidates should have a B.S. degree in a technical field and 2-3 years of relevant experience. This is a 100% onsite role with potential for extension based on performance.

Qualifications

• Minimum 2-3 years' experience in Operations or Technical Operations.
• Experience in relevant manufacturing or processing with knowledge of cGMP.

Responsibilities

• Support FLEx Center activities, including authoring/reviewing SOPs.
• Ensure compliance with safety rules and regulations.
• Identify and resolve operational problems.

Skills

Detail Oriented

Team player

Independent

Flexible

Education

B.S. Degree in Science

B.S. Degree in Engineering

B.S. Degree in other technical field

Tools

MS Office

SAP

Job description

Title:Operations Specialist - II (Associate)
Location:Rahway, NJ
Duration: 6+ months

Description:
• Incorporate scientific and technical knowledge to complete assigned tasks.
• Collaborate with internal stakeholders to drive effective communication and completion of deliverables.
• Understand priorities from manager/supervisor to ensure task completion.
• Understand/act on guidance from supervisor where decisions are guided by policies, procedures, and business plan.
• Identify and help to resolve standard day to day quality, technical, and operational problems.
• Make decisions guided by policies and standard operating procedures.
• Compliance: Responsible for sustaining a culture of compliance (Safety, Environment, cGMP).
• Exercise judgement and decision making to ensure quality product is reliably produced.
• Utilization of Client Leadership Behaviors and Ways of Working to promote daily work activities.
• Keep informed on current policies/procedures and all other FLEx Center communications.
• Comply with all safety rules and regulations and take prompt corrective action concerning potential safety hazards.
• Support compiling safety related documentation requirements (e.g. process waste identification/collection)
• Help to identify root causes of manufacturing issues and implement corrective action.
• Author/review documentation related to operational procedures and/or reports.
• Oversee equipment support, cleaning activities, and the review/approval SOPs and technical documents.
• Technical support for manufacturing and packaging activities.
• Support equipment and cleaning processes.
• Equipment administration management.
• Adaptive to learn new skills or processes (SAP) to drive functionality of the FLEx Center to meet objectives.

Quals--
Position Overview:
The Support Technician is an individual contributor with operational and technical responsibilities.
This position has multiple roles that include:-
(1) Supporting Formulation, Laboratory and Experimentation Center (FLEx Center) activities (CQ&V, author/review SOPs, SAP, etc.),
(2) Leveraging experience in drug product manufacturing to support daily manufacturing and cleaning operations (development & GMP activities) within the FLEx Center, and
(3) Leveraging scientific/technical capabilities to support R&D development program activities as needed. The Support Technician position will flex between roles when necessary to drive program and development needs.

Required Experience and Skills:
• Education Minimum Requirement: B.S. Degree in Science, Engineering or other technical field.
• Required Experience and Skills: Minimum (2-3) years' experience in a functional area, such as Operations, Technical Operations, Technology, Engineering.
• Preferred Experience and Skills: Minimum (2-3) years' experience in relevant manufacturing or processing (bulk, solid oral dosage, solutions/suspensions, packaging, etc.) with working knowledge of current good manufacturing procedures (cGMP)

Software expertise:
• MS office, Inventory management system like SAP.

Personality:
•Detail Oriented
•Team player
• Independent
•Flexible

Notes:
• 100% onsite role@ Rahway,NJ
• 6 months role with a possibility of extension based on performance and budget.
• Candidate should have valid work authorization, no visa assistance/sponsorship will be provided.

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