Production Operations Specialist
1 week ago
Position Overview:
This role requires a proactive individual who will ensure operational excellence and provide skill-based training both on the production floor and in training environments. The Production Operations Specialist will collaborate with manufacturing supervisors to conduct timely reviews of production records and documentation. This position serves as the primary resource for skill development training for Gel manufacturing personnel. Additionally, the specialist will contribute significantly to the implementation of Anika's Operational Excellence initiatives. Close collaboration with Operations management is essential to train staff on Lean manufacturing principles aimed at enhancing efficiency and minimizing waste. The specialist will work alongside area supervisors to guarantee optimal utilization of materials and equipment while monitoring the progress of process enhancements. This individual will also manage the ordering and tracking of Gel manufacturing materials through a Kanban system.
Key Responsibilities:
- Review completed Gel production records and documentation prior to submission for quality assurance.
- Facilitate training and scheduling for Operational Excellence, ensuring accountability for sustainability.
- Monitor operations readiness, including SAP/ERP material consumption, orders, transactions, and material availability. Execute necessary real-time ERP transactions related to material receipt or consumption.
- Serve as a subject matter expert for key processes within Gel manufacturing, performing critical tasks as needed and collaborating with supervisors to deliver comprehensive skill development training to junior staff. Evaluate staff skill levels and provide constructive feedback to supervisors.
- Revise and author standard operating procedures, batch records, and work instructions to enhance usability and compliance.
- Assist supervisors, engineers, and facilities with the initiation of Change Controls, CAPAs, deviations, or investigations of varying complexities, working with cross-functional teams to identify root causes.
- Implement process improvements and resolutions for existing and future manufacturing processes.
- Recommend and execute process enhancements or safety and ergonomic improvements.
- Participate in inspection readiness and support activities, conducting data analysis as required.
Supervisory Duties:
- Responsible for interviewing candidates as directed by management.
- Act as the primary contact for onboarding new manufacturing employees and serve as a resource and subject matter expert.
Required Experience, Knowledge, and Skills:
- Bachelor's degree in Chemistry, Chemical Engineering, or equivalent experience.
- Experience collaborating with technical leadership on projects.
- Basic proficiency in Microsoft Word, Excel, and PowerPoint.
- Strong verbal and written communication skills.
- Excellent organizational and tracking abilities with keen attention to detail.
- Capability to prioritize tasks and escalate issues when necessary.
- Proficient in performing real-time ERP transactions and material ordering.
- Willingness to work flexible hours to complete tasks.
- Ability to wear personal protective equipment, including safety glasses, gloves, and safety shoes.
- Capability to gown and access biotechnology or pharmaceutical manufacturing areas.
- Physical ability to lift, pull, or push equipment weighing up to 25-50 lbs.
- Ability to stand for extended periods in a production environment.
- Comfortable working with chemicals such as alcohols, acids, and bases.
Preferred Experience, Knowledge, and Skills:
- 6-8 years of experience in cGMP manufacturing with a High School Diploma or equivalent, or a Bachelor's degree in Chemistry, Chemical Engineering, or a related field.
- 2+ years of experience leading teams in a cGMP environment.
- Experience working in cleanroom settings or utilizing aseptic techniques.
- Familiarity with commercial-scale automated equipment and troubleshooting.
- Experience in a results-driven team environment.
- Proficient in performing ERP transactions using SAP and maintaining spreadsheets.
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