With minimal supervision this individual will deliver operational excellence and skill based training on and off the production floor. The Manufacturing Specialist will partner with manufacturing supervisors to perform an on-time review of batch records and exception documents. The Manufacturing specialist will be the point person for performing skills development training for Gel manufacturing operators. This position will also play a key role in the implementation of Anika’s Operation Excellence program. The Manufacturing specialist will work closely with Operations management to train personnel on Lean manufacturing concepts driving efficiencies while eliminating waste. Works with area supervisor to ensures efficient use of materials and equipment Tracks the progress of process changes/improvements. This individual will oversee the ordering and tracking of Gel manufacturing expensed materials through the use of a Kan Ban system.
- Reviews completed Gel production batch records and documentation prior to submission to quality assurance.
- Provides training and scheduling for Operational Excellence. Ensures ownership and accountability to ensure sustainability.
- Operations readiness, (monitor SAP/ERP material consumption, orders, transactions, material expiry and availability). Performs required real time ERP transactions affiliated with material receipt or consumption
- Act as subject matter expert for; Major processes within Gel manufacturing departments by performing critical steps when needed and collaborating with the supervisor to perform a full skill development training to junior staff. Assess staff skill sets and provide feedback to Supervisor.
- Revise and author standard operating procedures/batch records/work instructions to optimize usability and compliance.
- Assist supervisor/engineer/facilities with initiation of Change Controls, CAPAs, deviations or investigations of various complexities and work with cross-functional departments to identify root cause
- Implementing process resolutions and improvements on existing and future manufacturing processes.
- Recommend/implement process changes/improvements or safety/ergonomic improvements.
- Participate in inspection readiness and inspection support activities, performing data mining when required.
- Responsible for interviewing candidates (at managers discretion)
- Point of contact for new manufacturing employee onboarding and Act as a resource/SME.
Experience, Knowledge, and Skills Required:
- 6+ years of experience in cGMP manufacturing with High School Diploma or equivalency or Bachelors’ degree in Chemistry or Chemical Engineering or relevant experience or related field or previous relevant experience.
- 2+years of experience working with technical leadership on projects
- Basic knowledge of Microsoft Word, Excel and PowerPoint
- Excellent verbal and written communication skills.
- Excellent organizational/tracking skills and attention to detail.
- Ability to prioritize tasks and escalate when appropriate.
- Ability to perform computer based real time ERP transactions and material ordering.
- Ability to work flexible hours to complete work activities.
- Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes.
- Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas.
- Ability to lift, pull or push equipment requiring up to 25-50 lbs. of force.
- Ability to stand for 6 hours in a production suite.
- Ability to work around chemicals (alcohols, acids & bases).
Desired Experience, Knowledge, and Skills:
- 6-8 + years’ experience in cGMP manufacturing with High School Diploma or equivalency or Bachelors’ degree in Chemistry or Chemical Engineering or relevant experience or related field or previous relevant experience.
- 2+ Years Leading Teams/Personnel in cGMP Environment.
- Experience working in a clean room or using aseptic technique
- Experience using and troubleshooting commercial scale automated equipment
- Experience performing in and leading a result driven, team environment
- Experience performing ERP transactions using SAP and maintaining spreadsheets.
We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.