Work Location: St. Louis, Missouri Shift: Yes Department: LS-SC-PMLEDG Team G Recruiter: Guadalupe Barragan
Hring Manager: Rhett Mayfield
This information is for internals only. Please do not share outside of the organization.
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 (3rd): Sunday-Thursday 10:30 pm-7 am. Shift is new, so first months of training will be on 1st or 2nd shift.
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 3rd 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 of chemical packaging, manufacturing, or laboratory experience.
Preferred Qualifications:
College coursework in chemistry or other scientific field.
1+ years chemical weighing experience.
1+ years' experience in ISO/GMP regulated environment.
Experience leading teams or projects.
Written and verbal communication skills.
Strong knowledge of and ability to troubleshoot automated and semi-automated filling, capping, and labeling equipment.
Demonstrated leadership skills with ability to guide, train, and coach co-workers.
Understanding of safe chemical handling practices and methods.
Good time management/organizational skills.
Deep understanding of ISO and GMP requirements.
Strong computer skills including SAP and Microsoft Office.
Mechanical skills with ability to use pumps, electronic balances, and material handling equipment.
Experience leading lean manufacturing or operational excellence projects.
Strong math skills including metrics and conversions.
Good grasp of RCA and CAPA.
Ability to work well in a team setting.
Problem solving skills.
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.