QA Specialist Aseptic Operations (1st Shift & Weekend Nights)

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

Benefits offered by this job

Medical, prescription, dental, vision,

Life insurance

Disability benefits

Paid volunteer time

Time off and holidays

Job summary

Grand River Aseptic Manufacturing (GRAM) is seeking a Quality Assurance Specialist to support quality systems in the manufacturing and testing of aseptic drug products. You will oversee deviation and CAPA processes, batch record review, SOP creation and revision, and quality document reviews within a cGMP framework.

The role requires a Life Sciences degree with 2–5 years GMP experience, strong attention to detail, and proficiency in Word, Excel, and Outlook.

Qualifications

• Bachelor's degree in Life Sciences or related field plus 2–5 years GMP/related experience.
• Proficient with MS Word, Excel and Outlook.
• Knowledge of QA principles in pharma/biopharma/biotech manufacturing is preferred.

Responsibilities

• Provide on-the-floor QA oversight in warehouse and manufacturing to support compliance with procedures and documentation.
• Review and approve batch records and controlled documents.
• Perform QA reviews of in-process data, environmental monitoring and material releases.
• Participate in cross-functional teams to support quality investigations.
• Understand the relationship between deviations and CAPA within quality systems.

Skills

Quality assurance knowledge

GMP knowledge

Documentation review

Education

Bachelor's degree in Life Sciences or related field

Equivalent GMP/related experience

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 apply 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:

• 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!
• GRAM encourages giving back to our community by offering 16 hours of paid volunteer time per calendar year!
• 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!
• Employees earn 1 hour of time off for every 30 hours worked to use how you choose.
• 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!