The Inspection Operator Lead is responsible for overseeing Inspection processes for the performance of all necessary tasks within a non-classified area for the inspection of safe and effective sterile (injectable) pharmaceutical products. This role is an extension of the Inspection Systems Supervisor. Drive day to day operations and activities in order to meet key performance objectives. Assist in tracking metrics for the department. Carry out new tasks with limited direction. Has a willingness to be involved in and/or drive other initiatives within the department (studies, etc.). This role is expected to be able to make decisions involving resourcing and delegation of priorities when necessary.
Participates in and at times, leads all aspects of Inspection.
May coordinate and plan schedules of Inspection Operators.
Responsible for execution and completion of individual training per required curriculum and ability to train new/less experienced Operators.
Contributes to inspection management their knowledge of personnel and provides input during evaluations.
Set-up, operation, and troubleshooting of manufacturing equipment: including (but not limited to) Semi-Automated Inspection Machine, Automated Inspection Machine, and ancillary equipment (conveyors, etc.).
Ensure daily production is running optimally, in terms of defined KPIs related to output, quality, Environmental, Health and Safety (EHS)
Identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality.
Escalate issues standing in the way of production meeting quality and output targets to Supervisor in an open and honest way.
Participate in investigations and execute appropriate approved corrective / preventative actions for Inspection related processes.
Perform tasks as per established Good Documentation Practices.
Reviews documentation generated by daily activities (batch records, logbooks, etc.) for completeness prior to the end of the shift.
Facilitates necessary corrections and reinforcement training (as required).
Ability to review, revise, and provide input in drafting SOP's and cGMP's relative to the positions within Inspection.
Partner with other employees to ensure processes and products are in compliance with all local, state, and federal rules and regulations.
Assist in the development and execution of equipment/process qualification, validation, and protocols.
Mentors and monitors Inspection personnel for CGMP behavior.
Knowledge and understanding regulatory requirements such as 21CFR part 210 and 211, cGMP's, FDA, OSHA and other regulatory agencies.
Partner with Quality to ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee that processes are in cGMP compliance and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality.
Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform.
Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.
High School Diploma or GED required
Associate degree is preferred
3-5 years of related work experience in a cGMP regulated environment required
Strong Leadership skills required
Strong Mechanical abilities highly preferred
Willingness to work overtime (when required)
Pharmaceutical, Chemical, or related life science industry manufacturing experience highly preferred
Prior experience with complex high-speed manufacturing equipment preferred
Good technical experience with quality control technology including vision, robots, or automation preferred Knowledge of cGMP requirements preferred Must be able to learn and develop a working knowledge of cGMP's as needed.
Ability to evaluate equipment and processes and perform technical deep dives within own area preferred
Ability to clearly read and write English required
Xellia Pharmaceuticals is owned by Novo Holding A/S and is a specialty pharmaceutical company leading in the development, manufacture and supply of anti-infective treatments. Headquartered in Copenhagen, Denmark, Xellia has global facilities in Europe, North America, and Asia, currently employing over 1700 people. With over 100 years of industry experience in developing last resort treatments for infectious diseases, Xellia is focused on the supply of products which not only save lives, but also improve and enhance patients' quality of life. Together with us, you can help lead the fight against bacterial infections.