Grand River Aseptic Manufacturing Inc.
Manufacturing Supervisor (Weekend Nights)
Grand River Aseptic Manufacturing Inc., Grand Rapids, Michigan, us, 49528
Overview
The Manufacturing Supervisor’s primary responsibilities include managing routine manufacturing tasks while adhering to the guidelines of established procedures and cGMP regulations under direction of management and provide leadership to employees. This position primarily supports the Front Ave. facility, and the hours are primarily 6:00 pm to 6:00 am on Friday, Saturday, and Sunday. Non-Negotiable Requirements
Bachelor’s degree in life science or equivalent training and/or experience. Proven leadership experience and self-starter. Available for off-shift and on-call work, as needed. Proficient computer skills in Microsoft Word, Excel and Outlook. Preferred Requirements
Experience in aseptic manufacturing of regulated products with a thorough understanding of cGMP, FDA guidelines and regulatory/compliance standards preferred. Minimum 3 to 5 years of relevant pharmaceutical experience preferred. Experience in a CMO and sterile filling facility preferred. Responsibilities
Develop strategic visions for day-to-day tasks and implement an efficient resource delegation plan to optimize shift throughput in a high-output CMO facility. Provide leadership and oversight during component and equipment preparation, bulk drug formulation and aseptic filling duties. Accurately document data, complete batch records and execute documentation review as needed. Successfully complete facility gowning and media qualification program. Continually audit all personnel for compliance and use of proper aseptic technique. Operate production equipment. Perform duties in a Grade A sterile manufacturing facility. Support and enforce the departmental vision, goals and quality standards. Revise SOPs, forms and GMP documents for continual process improvement. Oversee operations in cleanroom environment. Communicate cross-functionally to provide schedule updates and information about any quality events. Participate in client communications, including problem solving, schedule development, and project status updates. Perform routine performance assessments with direct reports. Recognize inefficiencies and enact continuous improvement initiatives as corrective action. Complete proper, real time investigations and collects data for deviation/root cause analysis. Define and uphold disciplinary actions for poor performance of direct reports, as necessary. Foster a positive, affulent team environment that promotes productivity and employee satisfaction. Benefits
Medical Benefits starting day 1:
Blue Cross Blue Shield medical and dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying for 75% of the cost. We also offer consecutive 401(k) vesting and immediate GRAM contributions. We offer generous off-shift premiums. Paid Volunteerism starting day 1:
GRAM encourages giving back to our community by offering 16 hours of paid volunteer time per calendar year. PTO:
Full-time employees accrue up to 13 days of time off per calendar year. You choose how to use this time for vacation, sick, or mental health needs. Wellness Time Off:
Employees earn 1 hour of time off for every 30 hours worked to use as you choose. Paid Holidays:
We offer 10 paid holidays per calendar year with immediate eligibility. Pay:
Depends on experience and is discussed during the interview process. If you meet the required criteria listed above, GRAM welcomes you to apply today!
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The Manufacturing Supervisor’s primary responsibilities include managing routine manufacturing tasks while adhering to the guidelines of established procedures and cGMP regulations under direction of management and provide leadership to employees. This position primarily supports the Front Ave. facility, and the hours are primarily 6:00 pm to 6:00 am on Friday, Saturday, and Sunday. Non-Negotiable Requirements
Bachelor’s degree in life science or equivalent training and/or experience. Proven leadership experience and self-starter. Available for off-shift and on-call work, as needed. Proficient computer skills in Microsoft Word, Excel and Outlook. Preferred Requirements
Experience in aseptic manufacturing of regulated products with a thorough understanding of cGMP, FDA guidelines and regulatory/compliance standards preferred. Minimum 3 to 5 years of relevant pharmaceutical experience preferred. Experience in a CMO and sterile filling facility preferred. Responsibilities
Develop strategic visions for day-to-day tasks and implement an efficient resource delegation plan to optimize shift throughput in a high-output CMO facility. Provide leadership and oversight during component and equipment preparation, bulk drug formulation and aseptic filling duties. Accurately document data, complete batch records and execute documentation review as needed. Successfully complete facility gowning and media qualification program. Continually audit all personnel for compliance and use of proper aseptic technique. Operate production equipment. Perform duties in a Grade A sterile manufacturing facility. Support and enforce the departmental vision, goals and quality standards. Revise SOPs, forms and GMP documents for continual process improvement. Oversee operations in cleanroom environment. Communicate cross-functionally to provide schedule updates and information about any quality events. Participate in client communications, including problem solving, schedule development, and project status updates. Perform routine performance assessments with direct reports. Recognize inefficiencies and enact continuous improvement initiatives as corrective action. Complete proper, real time investigations and collects data for deviation/root cause analysis. Define and uphold disciplinary actions for poor performance of direct reports, as necessary. Foster a positive, affulent team environment that promotes productivity and employee satisfaction. Benefits
Medical Benefits starting day 1:
Blue Cross Blue Shield medical and dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying for 75% of the cost. We also offer consecutive 401(k) vesting and immediate GRAM contributions. We offer generous off-shift premiums. Paid Volunteerism starting day 1:
GRAM encourages giving back to our community by offering 16 hours of paid volunteer time per calendar year. PTO:
Full-time employees accrue up to 13 days of time off per calendar year. You choose how to use this time for vacation, sick, or mental health needs. Wellness Time Off:
Employees earn 1 hour of time off for every 30 hours worked to use as you choose. Paid Holidays:
We offer 10 paid holidays per calendar year with immediate eligibility. Pay:
Depends on experience and is discussed during the interview process. If you meet the required criteria listed above, GRAM welcomes you to apply today!
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