- Ensures compliance with cGMP, GLP, OSHA, EPA, US Commerce, DEA, NSSD, DOT, and FDA/EU regulations.
- Ensure that the Pilot Plant does not negatively impact clinical production status. Communicate production status and critical issues to operations, management, and support groups. Participate in shift change over meetings at beginning/end of shifts when applicable.
- Review and approve Process Safety Checklists prior to the start of a new process.
- Initiate Near Miss, Op Notes, and incident investigations for failure to comply with required safety, quality, and environmental regulations.
- Initiate, write and guide Development in writing development modifications.
- Review direction set content before manufacturing begins to assure all documentation and processing requirements are accounted for.
- Review direction sets to verify that the RDL's and DDL's used for cleaning verification are the most current.
- Perform and review of cleaning calculations required for equipment release from processing.
- Review direction sets while in process to assure all necessary steps are being completed correctly and in a timely manner.
- Review completed batch records before being sent to batch record review to identify/resolve issues.
- Ensure design review and pre-run meetings are completed. Ensure that shifts have an adequate number of trained staff for running processes.
- Maintain and audit regulatory logbooks and documentation.
- Work to resolve Corrective and Preventative Actions for quality metrics including calibration and Environmental Alerts.
- Review and sign off equipment/facility/utility VCR/MOC packages.
- Coordinate completion of utility/CNC+ (clean room) reinstatements.
- Track labor and equipment utilization.
- Provide timely feedback to employees on performance and areas of improvement. Work with employees to identify resources for areas of improvement.
- Bachelor's degree or equivalent; Six to Eight years' experience in all aspects of manufacturing/ production processes.
- Computer proficiency and scheduling experience required; good writing skills.
- Working knowledge of safety, quality systems, and cGMPs is required
- Familiarity with industrial automation (e.g., distributed control and PLC-based systems
- Familiarity with equipment and facilities validation
- Demonstrate excellent interpersonal skills by successfully collaborating with various departments on production needs.
- Work independently and in a team environment with various levels of personnel.
- Effectively handle multiple assignments and projects simultaneously
- Anticipate and adjust to rapidly changing priorities and anticipate the impact of the change on overall projects. Take initiative and identify new approaches to resolve problems regarding compliance and managing workloads.
- This position will work the second shift.
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
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Senior Shift Supervisor, API Pilot Plant, Second Shift - North Chicago, United States - AbbVie
Description
Job Description
Job DescriptionCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job DescriptionSupervise the operations, warehousing, and housekeeping personnel in the building during assigned shift. Work closely with the Technical Operations Support (Tech Ops) in planning production, evaluation of manufacturing capacity, and review of operational ability to perform process tasks. Work with Tech Ops and engineering to evaluate new/unique processes or unit operations and determine the requirements necessary to implement them in the plant. Communicate status of production and manufacturing issues to staff, management, and support groups. Assure staff meets all necessary training and certification requirements. Review direction sets prior to, during, and post manufacturing to identify potential issues and concerns. Initiate timely documentation of deviations/investigations of standard operations from compliance with quality, safety, and environmental events. Review and approve development modifications.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
