Production Technician

About the role

THIS IS A ROTATING 3RD SHIFT POSITION.

Responsibilities

• Performs production activities in accordance with volume fluctuation, business need, and effective procedures.
• Works to support production units by consistently providing required materials in a timely manner.
• Ensures all materials required for production are available prior to need.
• Identifies production issues and relays them to the leadership team.
• Ensures all required paperwork is complete, accurate and done in a timely manner to ensure accurate inventory.
• Completes tasks and corresponding documentation as required by cGMP.
• Works to prepare assigned areas for the oncoming shifts.
• Completes at least one developmental class annually focused on one of the four core competencies.
• Works to become trained in all assigned training modules.
• Trains and orients new team members (at any level) as assigned.
• Fulfills safety requirements by following all procedures put into effect to ensure your safety as well as the safety of others.
• Participates in monthly safety meetings.
• Reports all safety issues, concerns, incidents and near misses to the team leadership.
• Participates in safety walkthroughs coordinated by the department’s safety team.
• Provides input for potential safety issues as well as contributing ideas for corrective and preventative actions.
• Follows effective procedures to ensure the production of a safe and efficacious product.
• Works to understand cGMP’s.
• Identifies areas of deficiency to the leadership team and offers potential suggestions for improvements.
• Participates in both deviation investigations when appropriate and implementation plans to ensure a quality product.
• May participate in completion of quality documentation (BPR's, logbooks, etc.).
• FDA audit understanding and awareness.
• Participates in team meetings.
• Actively communicates improvement ideas, issues, concerns, etc to team.
• Participates in cross functional teams where necessary to complete projects in an effective and timely manner.
• Lead Operator, Completes picklists and move tickets for all tasks completed on any given day.
• This may require inputting data into SAP, along with entering work orders and reagent orders.
• Ensures proper process area operation by pre and post run set up and maintenance of lab and equipment.
• Recommends changes to BPRs, SOPS and SWIs were warranted.
• Writes and edits documents under supervision.
• Seeks out cross training in other areas whenever possible.
• Assists in writing and assisting incident investigations, CAPA's, change controls, along with assisting the higher-tech levels and Principal Investigators with projects.

Requirements

• A high school diploma or GED and 1+ years prior manufacturing work experience.
• An associates degree, two year technical degree or associated technical certificates/licenses from an accredited school with prior manufacturing work experience.
• A bachelor’s degree preferred.
• Evidence of basic mechanical aptitude, computer skills, good comprehension skills, retention skills, manual dexterity, and ability to troubleshoot.

Qualifications

• Basic mechanical aptitude.
• Good comprehension skills.
• Retention skills.
• Manual dexterity.
• Ability to troubleshoot.