Supervisor, Bulk Manufacturing

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 work

• 7AM – 330PMEST
• 3PM – 1130PMEST – 10% shift differential

For immediate consideration or more information, please contact me directly at or at .
9368264