Lead Production Technician

Main Responsibilities

• Performs production in accordance with volume fluctuation, business needs, and effective procedures.
• Ensures all materials required for production are available prior to need.
• Ensures the completion of sampling and corresponding documentation as required.
• Ensures the completion of move tickets and picklists in an accurate and timely manner to ensure accurate inventory.
• Participates or leads in all aspects of production process (SAP, cycle counting, Lims, iShift, ordering, Caps, Lab watch, Documentum, Metasys, DeltaV, 5S etc.).
• Works to resolve all production issues and guides others through the process to complete them.
• Understands science behind process steps and technology.
• Ensures all areas within the facility are adequately covered at all times.
• May serve as processing room leads and strive to become experts in their assigned areas.
• Completes tasks and corresponding documentation as required by cGMP.

Continues Development

• Completes at least one developmental class annually.
• Completes at least one developmental class outside of the core competencies annually.
• Works to become trained in all assigned training modules.
• Train and guide personnel in proper work procedures, use of equipment, cGMPs, safe work techniques and SAP to assure timely signoffs and consistency in training.
• Maintains qualified trainer status.

Safety

• Follows all procedures put into effect to ensure safety of self and others.
• Participates in monthly safety meetings.
• Reports all safety issues, concerns, incidents and near misses to team leadership.
• Actively participates in safety walkthroughs coordinated by the department's safety team.
• Provides input for potential safety issues and contributes ideas for corrective and preventative actions.
• Works with the safety team to ensure regular walkthroughs and timely resolution of issues.
• Works with the safety and leadership team to implement all safety initiatives.
• Ensures training is completed on all safety implementations.

Follows all procedures

• Follows effective procedures to ensure the production of a safe and efficacious product.
• Has a thorough working knowledge of the cGMPs and helps others understand.
• Identifies areas of deficiency and offers suggestions for improvements.
• Identifies deviations and aids in investigations and root cause analysis.
• Completes quality documentation (BPRs, logbooks, QA Observations etc.) accurately in a timely manner.
• Reviews quality documentation for completeness.
• Understands the function of the quality group and works with them to maintain a positive rapport.
• Participates in team meetings and cross functional teams where necessary to complete projects effectively and timely.