Supervisor, Bulk Manufacturing
Kelly Science and Clinical is currently recruiting for 2 qualified, full-time, permanent Bulk Manufacturing Supervisors in the Rochester, Michigan area for one of our clients in the pharmaceutical space. Responsibilities: Responsible for daily coordination and execution of working schedules of people and equipment in Bulk Formulation. Responsible for supervising hourly union operators that perform dispensing and formulation of a variety of drug and biological products, including company branded, development & generic as well as contract customer products while meeting department quality, safety, delivery, and productivity objectives. Reviews and releases batch record documentation; completes yield transactions or component returns. Ensures people and processes comply with Good Manufacturing Practices, company procedures, and the union contract. Modifies department standard operating procedures, investigates excursions, and executes change controls to support business and quality objectives. Establishes & maintains cooperative cross-functional relationships with peers in Quality, Sterile Operations, Process Development, and Supply Chain to meet plant objectives. Supervises 8-10 hourly workers. Significant equipment includes formulation vessels (sterile and non-sterile), lab equipment (pH, DO, Temperature), scales, and automatic filter integrity testers. Oversees hourly operators in execution of daily work; assures operators comply with validated parameters and standard operating procedures. Responsible for schedule adherence; participates in scheduling meetings with the objectives of increased resource utilization. Responsive to changes in daily workflow and schedule; determines needs & redeploys resources and/or overtime to achieve delivery & customer service commitments; adapts to ebb/flow of production process including changes due to unplanned maintenance or events requiring investigation. Ensure all equipment is working properly. Completes final batch record reviews for Bulk formulation and Drug & Chemical. Completes in-process checks & verifications in alignment with Standard Operating Procedures.33%
Compliance Understands & adheres to good documentation practices (GDP) Executes Quality Management System assignments (CAPA, Deviation, Change Control, Standard Operating Procedures etc.) to on-time closure. Obtains knowledge and executes assignments in QMS areas: deviation management and/or change control. Conducts investigations for cause, determines corrective action, and impact; writes reports & assures timely closure. Initiates & executes change control assignments in support of continuous improvement initiatives for equipment, documentation, or processes. Initiates and approves maximo work orders. Creates, reviews, and conducts operator training programs & assures operator training is conducted on SOPs, cGMP, and safety. Assure and assist classroom and hands on training for batch records, SOP's, and cGMP's, and maintain proper documentation to ensure compliance. Follow and comply with company Safety policies and OSHA Regulations Participates in development & maintenance of a safe manufacturing environment. Establishes methods in compliance with regulatory, plant, and corporate policies. Participates in safety meetings, investigates accidents, and takes appropriate corrective action to eliminate hazardous conditions.33%
Supervisory Reports production updates & schedule changes to team and/or at daily Huddle/SMART meetings. Assures hourly operators comply with all procedures, GMP regulations, safety, and contract obligations; provides constructive operator feedback. Assigns manpower; Initiates documentation of violations and disciplinary action with operators as required. Requests equipment and facility repairs, or modifications. Understands & complies with Union Agreement.33%
Leadership Reviews operational performance; executes improvement opportunities. Counsels, trains, & develops union colleagues for efficient performance; creates an atmosphere of team effort & open communication. Consistently communicate, follow, and enforce SOP's and company policies and guidelines set forth in the employee handbook. Troubleshoots or resolves issues impeding department daily/weekly deliverables; proactively demonstrates the ownership to achieve. Interfaces with suppliers of equipment or products and area consultants/experts Supports CMO audits or regulatory agency inspections. Qualifications/Education/Skills: Required - B.A. /B.S. Degree in Science, Business or related field, B.A. or B.S. Degree in Science desirable.1-3 years' experience in Pharmaceutical Packaging, Operation or Quality Department desired Knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc. Able to understand & comply with all current state, federal and local standards and regulations, such OSHA, EEOC, EPA, FDA, and DEA Knowledge of MS Office Suite Ability to acquire knowledge/use of Enterprise Resource Planning tools (JD Edwards); Quality MS (Management Systems), Document MS, Learning MS (Trackwise, Master Control, ComplianceWire respectively), Kronos, and Maximo PHYSICAL REQUIREMENTS : Occasionally required to reach with hands and arms and stoop, kneel, crouch, or crawl. Specific vision abilities required by this job include close vision. Frequently working near or exposed to moving mechanical parts. The noise level is moderate. Occasional exposure to fumes, airborne particles, toxic or caustic chemicals Work environment is a production/manufacturing plant. May be required to be cleanroom gown qualified. Pay : $75-85K/yr and based on experience
Hours: 2 shifts available, M-F, with alternating weekend work7AM – 330PMEST3PM – 1130PMEST – 10% shift differentialFor immediate consideration or more information, please contact me directly at or at .
9368264
