QA Specialist - Aseptic Operation (1st Shift)

Grand River Aseptic Manufacturing Inc.; Grand Rapids (MI); In loco; USD 65.000 - 90.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, prescription, dental, vision

Life insurance

Disability benefits

401(k) with company contributions

Paid volunteer time

PTO and wellness time off

Paid holidays

Descrizione del lavoro

Grand River Aseptic Manufacturing (GRAM) is seeking a Quality Assurance Specialist to support cGMP drug product manufacturing and testing. You will oversee manufacturing documentation, deviations and CAPA, and batch records while supporting the Quality Management System.

Non-negotiable requirements include a Life Sciences degree and 2–5 years of related experience, plus strong computer skills. The role offers comprehensive benefits and growth in a fast-paced, compliant environment.

Competenze

• Bachelor's degree in Life Sciences or related field; 2–5 years of related work experience, or equivalent GMP experience.
• Must perform tasks with accuracy and efficiency.
• Proficient with Word, Excel and Outlook.

Mansioni

• Provide on the floor quality oversight within warehouse and manufacturing areas to support SOPs and documentation.
• Establish and maintain proper gowning and cleanroom technique in classified areas.
• Review and approve batch records and other controlled documents.
• Perform QA review of in-process results, environmental monitoring, and material release for incoming materials.
• Participate in cross-functional teams to support quality investigations.
• Understand the relationship between deviations and CAPA within quality systems.

Conoscenze

Attention to detail

Documentation skills

GMP knowledge

Team collaboration

Problem solving

Formazione

Bachelor's degree in Life Sciences

Strumenti

Microsoft Word

Microsoft Excel

Outlook

Descrizione del lavoro

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:

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.