Supervisor - Bulk Manufacturing Job Listing at Kelly Services in Rochester, MI (Job ID 9315497)

Description

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 Tierra.Barbour@kellyscientific.com or at 804-991-0745.
 

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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