QA Specialist - Finishing Operations (1st Shift)

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

Descrizione del lavoro

Grand River Aseptic Manufacturing (GRAM) is seeking a QA Specialist I in Finishing Operations to support quality systems for parenteral drug manufacturing and testing. You will oversee terminal sterilization, visual inspection, labeling and packaging activities and release materials as part of the QA process.

The role requires 1–2 years of related experience, knowledge of QA in pharma, and proficiency with Word, Excel and Outlook.

Competenze

• 1–2 years related work experience.
• GMP/pharma QA knowledge.
• Proficient with Word, Excel and Outlook.
• Equivalent GMP experience may replace the degree.

Mansioni

• Verify compliance with terminal sterilization, visual inspection, labeling and packaging operations documentation during operations.
• Review executed batch records and other controlled documents.
• Perform clearances and start-up activities for Finishing Operations and related equipment.
• Perform QA review and approval of stability and finished products testing certificates of analysis.
• Perform QA review and material release for incoming materials.
• Adhere to cGMPs and SOPs and support quality investigations (NCRs, LIRs).

Conoscenze

QA principles

GMP knowledge

cGMP

Microsoft Word

Microsoft Excel

Microsoft Outlook

Formazione

Bachelor's degree in Life Sciences

Strumenti

Microsoft Word

Microsoft Excel

Microsoft Outlook

Descrizione del lavoro

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 QA Specialist I in Finishing Operations supports the quality systems as they relate to the manufacturing and testing of cGMP drug products. Provides quality oversight for terminal sterilization, visual inspection, labeling and packaging of parenteral drugs. Performs the quality release of incoming materials. Reviews documentation and quality records.

Non-Negotiable Requirements:

• 1-2 years related work experience.
• In lieu of a bachelor's degree, equivalent GMP/related work experience may be considered.
• Knowledge of QA principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.
• Must have proficient computer skills in Microsoft Word, Excel, and Outlook.
• Must have basic computer skills such as Microsoft Word, Excel and Outlook.

Preferred Requirements:

• Bachelor's degree in Life Sciences or related field
• Experience working in a pharmaceutical or other regulated environment.

Responsibilities Include (but are not limited to):

• Verify compliance with terminal sterilization, visual inspection, labeling and packaging operations documentation during operations.
• Review executed batch records and other associated controlled documents.
• Perform clearances and start-up activities associated with Finishing Operations and Weigh and Dispense Booth operation.
• Perform QA review and approval of stability and finished products testing certificates of analysis.
• Perform QA review and material release for incoming materials.
• Perform routine tasks within the quality systems, such as Work Orders, Calibration Forms, etc.
• Understand and be able to perform job responsibilities in compliance with cGMPs, company standard operating procedures, and industry best practices.
• Participate in deviation investigation teams to support quality investigations (NCRs, LIRs etc.).

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!
• 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.