Senior Production Technician

Senior Production Technician

Requirements

• HS diploma or equivalent and 3+ years in cGMP or Pharmaceutical experience
• Associates with 2 + yrs in cGMP or Pharmaceutical experience
• Bachelors with 1 + yrs in cGMP or Pharmaceutical experience

Responsibilities

• Performs production in accordance with volume fluctuation, business need, 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 the production process (SAP, cycle counting, LIMS, Trackwise, Ordering, Labwatch, Qualipso, Metasys, etc.).
• Works to resolve all production issues.
• Understands the next steps and works to guide others through the process to complete them.
• Understands the 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 by completing at least one developmental class annually.
• Works to become trained in all assigned training modules.
• Train and guide Personnel in proper work procedures, use of equipment, cGMP’s, safe work techniques and SAP to assure timely qualifications and consistency in training.
• Maintains qualified trainer status.
• Follows 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 leader.
• 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.
• Works with the safety team to ensure that the team is completing regular walkthroughs and is taking the necessary steps to address issues.
• Works with the safety team to ensure that the resources required to address safety issues are secured in a timely manner and that the effective resolutions are put into place and trained upon.
• Works with the safety and leadership team to implement all safety initiatives by actively and effectively communicating the initiatives and by helping others to understand the initiatives.
• Ensures training is completed on all safety implementations.
• Follows effective procedures to ensure the production of a safe and efficacious product.
• Has a thorough working knowledge of the cGMP’s and works to help others understand.
• Identifies areas of deficiency and offers suggestions for improvements.
• Identifies deviations and aids in investigations and root cause analysis.
• Works to complete quality documentation (Electronic Logbooks and Batch Records) accurately in a timely manner.
• Review quality documentation for completeness.
• Understands the function of the quality group and works with them to maintain a positive rapport.
• Participates in cross-functional teams where necessary to complete projects in an effective and timely manner.
• All other duties as assigned.

Preferred Qualifications

• Prior or related cGMP or Pharmaceutical experience recommended
• Proficiency in at least two areas of operations or product line.
• Must be a qualified trainer in one or more areas.
• Must be proficient in at least one of the following areas: Batch record review, Environmental monitoring, logbook review, technical writing (SWI revisions).
• Must have knowledge and access to systems (SAP, Qualipso, Master Labware, Opstrakker). Must have knowledge and access to systems in applicable buildings and processes which have these systems (SFD, PI).