Sampling Associate (1st & 2nd Shift)

Grand River Aseptic Manufacturing Inc.; Grand Rapids (MI); On-site; USD 42,000 - 54,000; Full time

Benefits offered by this job

Benefits starting day 1

Paid volunteerism starting day 1

PTO: 13 days/year

Wellness time off

Job summary

Grand River Aseptic Manufacturing (GRAM) invites applicants to join as a Finishing Technician I, coordinating internal sample pulls and inspections. You will work with Sample Coordinators, Supply Chain, Quality, Operations, Continuous Improvement, Validation, MSAT, and Project Management to support site objectives.

The role requires a High School Diploma/GED, proficiency in Word, Excel, Outlook, and experience with pharmaceutical packaging and cGMP.

Qualifications

• High School Diploma or GED is required.
• Pharmaceutical packaging experience and knowledge of cGMP and FDA guidelines are required.

Responsibilities

• Perform sample pulls with complete documentation (SOPs, protocols, reports).
• Inspect and document GMP/non-GMP samples and Master Batch Records for Sample Management.
• Collaborate cross-functionally with Operations, Engineering, Maintenance, Project Management, Quality, and MSAT to gather data for sample submissions.

Skills

MS Word

Excel

Outlook

Education

High School Diploma/GED

Associate degree

Job description

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:

In addition to working as a Finishing Technician I and performing the essential duties and responsibilities of that role, this role coordinating internal sample pulls and inspections. This position will work closely with the Sample Coordinators, Supply Chain, Quality, Operations, Continuous Improvement, Validation, MSAT, and Project Management to support site objectives.

Non-Negotiable Requirements:

• High School Diploma/GED
• Proficiency in Microsoft Word, Excel, and Outlook
• Ability to maintain Visual Inspection Qualification testing
• Experience in pharmaceutical packaging of regulated products with a thorough understanding of cGMP, FDA guidelines and multinational regulatory standards required.

Preferred Requirements:

• Associate degree or equivalent
• Experience working in a pharmaceutical or other regulated environment.
• Experience in a warehouse environment, processing orders, or inventory control.

Responsibilities Include (but are not limited to):

• Perform sample pulls that contain pertinent sampling documentation (SOPs, protocols, reports, etc.).
• Pull, inspect and complete GMP and non-GMP documentation for use in Sample Management including, but not limited to in-process samples, PPQ/ENG samples, media fill samples, incoming samples, finished goods samples, logs, forms, and Master Batch Records.
• Effective cross-functional collaboration with Operations, Engineering, Maintenance, Project Management, Quality, Operational Excellence, MSAT, and any other pertinent department to ensure all documentation (and respective data) is gathered in an expeditious manner for timely completion of sample submissions.
• Follow applicable procedures regarding communication of sample pull, shipments, operations, quality, compliance, chain of custody, sample retention, sample storage, controlled substance, and GDPs.
• Assist with roadblocks that may impact successful sample pull and inspection to Sampling Management and Sample Coordinators.
• Adhere to established Key Performance Indicators and project timelines.
• Take corrective action by thinking creatively and problem solving to develop innovative solutions based on sound scientific analysis.
• Support Agency, customer and vendor audits as needed.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.

Full job description available during formal interview process.

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!