Inspection Line Lead (1st Shift)

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:

 Oversee the execution of tasks and attainment of departmental goals while assisting the Inspectors in operations. Responsible for operating and leading all Inspection equipment and area while directing operators. Coordinate applicable training tasks with Finishing Trainer and Supervisors to meet all guidelines of established procedures and cGMP regulations. Support Finishing Area tasks, as needed. 

Non-Negotiable Requirements:

•  1+ years relevant experience as a qualified inspector of parenteral products. 
•  Knowledge of QA principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment. 
• Experience in pharmaceutical inspection of regulated products with a thorough understanding of cGMP, FDA guidelines and multinational regulatory standards. 
• Knowledgeable of GMP standards and the ability to follow CFR guidelines. 
• Ability to work overtime and weekends, as necessary. 
• Must have proficient computer skills in Microsoft Word, Excel and Outlook. 

Responsibilities Include (but are not limited to):

• Provide direction and support to the inspection team to ensure cleanliness, organization, and maintenance of the operational areas and equipment. 
• Verify and classify rejects. Provide feedback to inspectors as needed. 
• Perform equipment set up and operation. 
• Perform Good Documentation Practices with accuracy and according to regulatory guidelines 
• Assist in completion of batch record materials. 
• Ability to navigate through Master Control and its general use. 
• Maintain data trending reports from visual inspection data. 
• Train all inspection employees, with support from Finishing Trainer. 
• Document and communicate professionally, upward/downward, with all Finishing and cross-functional teams. 
• Actively participate in Continuous Quality and Safety Improvements. 
• Support Agency, customer and vendor audits as needed. 

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! PTO: Full-time employees accrue up to 13 days of time off per calendar year. You choose how to use this time for your vacation, sick, or mental health needs!

WELLNESS TIME OFF: Employees earn 1 hour of 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. 

If you meet the required criteria listed above, GRAM welcomes you to apply today!  

Full job description available during formal interview process.