Packaging Team Lead - Weekend Shift

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This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role:

At MilliporeSigma, the Packaging Team Lead will lead, coordinate and participate in all aspects of filling, capping, torquing, and labeling of products done in an ISO 13485 environment. The Packaging Team Lead will be expected to complete appropriate packaging documentation per FDA, ISO, and GMP procedures and deliver products into inventory.

Job Functions:

• Shift: Friday-Sunday 7am-7pm.
• Oversee packaging operations ranging from large scale bulk pumping and transfer to small scale bench top filling with a pipette (Many products will require filtration and aseptic handling techniques).
• Provide guidance, instruction, and feedback to packaging operators performing daily work.
• Become trained and serve as Emergency Response Team Member on weekend shift.
• Lead shift when supervisor is out of office.
• Play a key role in the training and development of packaging staff.
• Work with packaging team and manufacturing to ensure time-sensitive make/fills and other key priority products are completed on time.
• Assist with planning the daily schedule when necessary.
• Support the daily management system (DMS) to ensure key performance targets are met.
• Ensure documentation is accurate and timely.
• Perform SAP transactions as needed to keep orders moving.
• Utilize expertise in manual and automated packaging to help troubleshoot equipment and processes.
• Support site quality system by assisting with deviation and complaint investigations, change control, and document updates.
• Lead and champion automation and operational excellence projects to enhance the safety, quality, and productivity of the packaging operation.
• Assist in interviewing and selecting new packaging operators.
• Provide recommendations for capital expense requests.
• Assist in performing instrument qualifications, operation qualifications, and validation.
• Be actively involved in technical support for evaluating business development opportunities.
• Follow all quality and safety procedures.

• Support quality systems.
• Follow safety procedures at all times.
• Document all equipment used and verify calibration status.
• Utilize computerized data collection system to generate fill line report for batch record.
• Ensure timely and accurate documentation of all line operations.
• Oversee compilation of batch records and all ancillary documentation.
• Don, doff, use, and clean PPE.
• Be familiar with hazards common to assigned work and take action to correct unsafe situations.
• Participate in required safety activities such as training sessions, meetings, and safety inspections.
• Develop and assist in the implementation of process improvement ideas.
• Comply with the requirements of ISO 13485 and ISO 9001.
• Participate in 6S activities.
• Maintain good housekeeping and audit readiness.
• Assist in performing instrument qualifications, operation qualifications, and validations.
• Assist in writing and updating equipment specific Ops.

Physical Attributes:

• Ability to walk, stand, bend, twist, lift, and carry up to 50 pounds independently on consistent basis, lift/reach overhead, visual ability, and manual dexterity.

• Perform moderately physical activity.
• The employee may work near moving mechanical parts; fumes or airborne particles; toxic or hazardous chemicals.
• The noise level in the work environment is usually moderate.
• Specific vision requirements of this job include close vision, distance vision, color vision, peripheral vision, depth vision and the ability to adjust focus.

Who You Are:

Minimum Qualifications:

• High School Diploma or GED.
• 3+ years' experience in chemical packaging, manufacturing, or laboratory experience.

Preferred Qualifications:

• College coursewor