**Supervisor, Aseptic/Sterile Fill – Rochester MI** Kelly Science and Clinical is currently recruiting for one qualified, full-time, permanent Aseptic/Sterile Fill Supervisor position in the Rochester, Michigan area for one of our clients in the pharmaceutical space. **Responsibilities:** + Oversees hourly operators by ensuring compliance with validated parameters and SOPs. + Develops daily/weekly department work schedules, set priorities, and verifies availability of resources. + Participates in scheduling meetings with the objectives of increased resource utilization. + Responsive to changes in daily workflow and schedule and determines needs and redeploys resources and/or overtime to achieve delivery and customer service commitments. + Adapts to ebb/flow of production process including changes due to unplanned maintenance or events requiring investigation. + Reviews batch records and supporting records prior to submission to Quality. + Maintains a safe work environment. + Completes in-process, set up checks and verification in alignment with SOPs. + Understands and adheres to GDPs. + Executes QMS assignments (CAPA, Deviation, Change Control, SOPs, etc.) + 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 and assures timely closure. + Initiates and executes change control assignments in support of continuous improvement initiatives for equipment, documentation, or processes. + Initiates and approves work orders for equipment repairs or modifications. + Creates, reviews, and conducts operator training programs and assures operator training is conducted on SOPs, cGMP, and safety. + 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 Supervisory. + Reports production updates and schedule changes to team and/or at daily Huddle or SMART meetings + Assigns manpower and initiates documentation of violations and disciplinary action with operators as required. + Requests equipment and facility repairs, or modifications + Understands and complies with Union Agreement + Keeps manager informed of operations; elevates as needed Leadership. + Reviews operational performance and drives improvement opportunities. + Troubleshoots or resolves issues impeding department daily/weekly objectives/deliverables. + Interfaces with suppliers of equipment or products and area consultants/experts + Conducts/supports CMO audits or regulatory agency inspections. **Qualifications/Education/Skills:** + B.A./B.S. Degree in Science, Business, or related field or significant experience; B.A. /B.S. Degree in Packaging, Science and/or Management degree highly desired + 1-3 years in Pharmaceutical Packaging, Operation or Quality Department with increasing levels of responsibility or equivalent Knowledge required. + Knowledge of QMSs, Learning MSs (Trackwise, Master Control, and ComplianceWire respectively) + Proficient in MS Office Suite, Kronos, Maximo + Solid understanding of all current state, federal and local standards, and regulations, e.g., cGMP, OSHA, EEOC, EPA, FDA, and DEA + _NOTE: Personnel from outside the pharmaceutical industry or a directly related industry, i.e., medical devices, food, etc.,_ _may_ _be considered after critical assessment of their industry related knowledge_ . + **Must be able to gain knowledge and expertise in aseptic processing.** **Top preferred skills:** + BS degree is required for upward growth within the company. Science degree would be highly beneficial, such as chemistry, biology, microbiology degrees. + Union experience as well as supervisor experience; must have demonstrated leadership experience. + 1-3 years in Pharmaceutical Packaging, Operation or Quality Trackwise software experience would be a huge plus as well as Compliance wire software, Infinity QS software, and QMS specific to batches. **PHYSICAL REQUIREMENTS** : + Routine entry into a manufacturing environment that requires garbing in and out of environmentally controlled areas up to ISO Grade 5. + Occasionally required to reach with hands and arms and stoop, kneel, crouch, or crawl. + Frequently working near or exposed to moving mechanical parts. + The noise level is moderate. + Occasional exposure to fumes, airborne particles, toxic, or caustic chemicals **Pay** : $75-85K/yr and based on experience **Hours:** 11PM - 730AMEST, M-F – 15% shift differential - **some daily and weekend OT is required for this role. There is a stipend for additional OT hours worked as this is a salaried role.** 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 (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) 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. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. 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.