Job Description

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. 

Follows all procedures put into effect to ensure your safety as well as the safety of others. 

Participates in monthly safety meetings. 

Report all safety issues, concerns, incidents and near misses to the team leadership. 

Actively 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. 

Write and edit documents under supervision. 

Seeks out cross training in other areas whenever possible. 

Responsible for assisting in writing and assisting incident investigations, CAPA's, change controls, along with assisting the higher tech levels and Principal Investigators with projects.

All other duties as assigned.

BASIC QUALIFICATIONS:

S/GED with at least 1 year prior manufacturing work experience or.

Associates degree with prior manufacturing work experience.

Prior or related cGMP or Pharmaceutical experience recommended.

Must have basic mechanical aptitude, computer skills, good comprehension skills, retention skills, manual dexterity, and ability to troubleshoot.