QA Specialist Aseptic Operations (1st, 2nd, 3rd, Weekend Days, Weekend Nights)

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, and vision insurance

401(k) with immediate vesting

Paid volunteer time

Paid time off (PTO)

Wellness time off

Paid holidays

Paid holidays

Job summary

A leading pharmaceutical manufacturer in Grand Rapids, Michigan, is seeking a Quality Assurance Specialist to ensure compliance with quality systems in manufacturing drug products. The ideal candidate has a Bachelor's degree in Life Sciences or a related field and 2-5 years of relevant experience. Responsibilities include providing oversight in manufacturing areas, approving batch records, and supporting quality investigations. The company offers competitive benefits starting from day one, including medical coverage, PTO, and paid volunteer hours.

Qualifications

• 2-5 years related work experience in pharmaceutical or biotech manufacturing.
• Understanding of quality assurance principles and procedures.
• Ability to perform quality oversight with minimal guidance.

Responsibilities

• Provide quality oversight within warehouse and manufacturing areas.
• Review and approve executed batch records.
• Participate in quality investigations.
• 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

Accuracy

Proficient in Microsoft Word

Proficient in Microsoft Excel

Proficient in Microsoft Outlook

Education

Bachelor’s degree in Life Sciences or related field

2-5 years GMP/related work experience

GMP experience in lieu of degree

Tools

Microsoft Word

Microsoft Excel

Outlook

Job description

Overview

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.

We welcome you to apply if you meet the required criteria listed above.