QA Specialist - Aseptic Operation (1st Shift)

Grand River Aseptic Manufacturing, Inc.; Grand Rapids (MI); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical, prescription, dental, vision,

Life insurance and disability benefits

401(k) with immediate vesting

Paid volunteer time

PTO

Wellness time off

Paid holidays

Job summary

Grand River Aseptic Manufacturing, Inc. (GRAM) seeks a Quality Assurance Specialist to support quality systems for aseptic drug product manufacturing and testing. You will oversee deviation and CAPA processes, batch record reviews, SOP revisions, and quality document reviews within a cGMP environment.

The role requires a Life Sciences degree (or equivalent GMP experience) and 2–5 years in a related field, with strong MS Word/Excel/Outlook skills. On-site work in Grand Rapids, MI, is expected.

Qualifications

• Bachelor’s degree in Life Sciences or related field, with 2–5 years related GMP/pharma experience.
• Ability to complete tasks with accuracy and efficiency.
• Proficient computer skills in MS Word, Excel, and Outlook.

Responsibilities

• Provide on the floor Quality oversight within the warehouse and manufacturing areas to support compliance with procedures and manufacturing documentation during operations with minimal guidance.
• Establish and maintain good technique with regards to working in classified areas (including gowning qualification).
• Review and approve executed batch records and other associated controlled documents.
• Perform QA review in-process, environmental monitoring test results, and material release for incoming materials.
• Participate in cross functional teams to support quality investigations.
• Perform tasks within the quality systems with an understanding of the correlation between systems, such as the relationship between a deviation and CAPA.

Skills

Attention to detail

MS Word/Excel/Outlook

Clear communication

Education

Bachelor's degree in Life Sciences or related field

Tools

Microsoft Word

Microsoft Excel

Outlook

Job 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 join our community of dedicated individuals improving lives every day!

Overview of this Position:

The Quality Assurance Specialist supports quality systems as they relate to the manufacturing and testing of cGMP drug products. The Quality Assurance Specialist provides oversight and general support for the manufacturing of aseptic processes, deviation and CAPA systems, batch record review, SOP creation and revision, review of quality documents, and supports the Quality Management System.

Non-Negotiable Requirements:

• Bachelor’s degree in Life Sciences or related field, and 2-5 years related work experience. In lieu of a bachelor’s degree, equivalent GMP/related work experience may be considered.
• Ability to complete tasks with accuracy and efficiency.
• Proficient computer skills in Microsoft Word, Excel, and Outlook.

Preferred Requirements:

• Knowledge of quality assurance principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.

Responsibilities Include (but are not limited to):

• Provide on the floor Quality oversight within the warehouse and manufacturing areas to support compliance with procedures and manufacturing documentation during operations with minimal guidance.
• Establish and maintain good technique with regards to working in classified areas (including gowning qualification).· Review and approve executed batch records and other associated controlled documents.
• Perform QA review in-process, environmental monitoring test results, and material release for incoming materials.
• Participate in cross functional teams to support quality investigations.
• Perform tasks within the quality systems with an understanding of the correlation between systems, such as the relationship between a deviation and CAPA.

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.