Weekday Batch Analyst Jobs (NOW HIRING)

Description

Agility, Impact, Methodology. Do you exhibit these values and wish to be around others that do too? Do you thrive in fast-paced environments where agility, adaptability, and high standards go hand in hand? Are you driven to make a meaningful impact, whether through your work, your support of others, or your commitment to your community? Are you motivated by a disciplined, science-based approach that ensures consistent excellence, safety, and integrity in everything you do? If these statements resonate with you, Grand River Aseptic Manufacturing (GRAM) welcomes you to apply to join our community of dedicated individuals improving lives every day!

Overview of this Position:

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. The primary location for this role is the Butterworth Facility, on shift C (Monday - Wednesday, and every other Thursday, from 6:00 pm to 6:00 am).

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 Include (but are not limited to):

• 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, affluent team environment that promotes productivity and employee satisfaction.

What Sets GRAM Apart from Other Employers:  

BENEFITS starting day 1: Medical, prescription, dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying a portion of the cost! Once eligible for the 401(k) program, all your contributions are immediately 100% vested, and you are immediately vested in GRAM contributions as well. We also 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!

PAID TIME OFF: You choose how to use this time for your vacation, sick, or mental health needs! PTO: Full-time employees accrue up to 104 hours of paid time off per calendar year, with this amount being prorated your first year. WELLNESS TIME OFF (WTO): In addition to PTO, employees earn 1 hour of wellness time off for every 30 hours worked, to use how 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.