Compliance Specialist II

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 Compliance Specialist supports and upholds the quality management system to ensure the consistent manufacture and testing of cGMP compliant drug products. These duties include providing oversight and general support of the compliance processes at Grand River Aseptic Manufacturing including, but not limited to, authoring annual product quality review reports, conducting internal audits, hosting client audits, supporting external regulatory audits (e.g. FDA, EU), writing effective audit reports, following up on audit responses and commitments internal and external, and oversight and enforcement of the DEA registration. This is an on-site role.

Non-Negotiable Requirements:

• Bachelor's degree in Life Sciences or applicable relevant experience.
• QA/QC professional with a minimum of 5 years' experience within a pharma, biopharma and/or biotech manufacturing environment.
• Must have proficient computer skills in Microsoft Word, Excel, PowerPoint, and Outlook.

Preferred Requirements:

• Certified Quality Auditor (CQA) certification preferred, or the ability to study, test and receive certification quickly.
• Experience in an aseptic manufacturing environment.

Responsibilities Include (but are not limited to):

• Support quality systems that may include Regulatory Surveillance, Annual Product Reviews, Controlled Substance Program, customer complaints, internal audits, and external audits.
• Supports work such as assisting with preparation, review and drafting of annual product reviews; Coordinating routine DEA inventory assessments; Reporting annual controlled substance inventory to the state of Michigan.
• Actively host client and prospective client audits, which may include coordinating requests, preparing subject matter experts for interviews, delivering GRAM welcome presentation, discerning and communicating the focus of the auditors, capturing dialogue/notes during audit, preparing and following up on audit responses to clients.
• Actively support regulatory inspections as preparation coordinator. Respond to, coordinate and fill requests, organize SMEs in support of regulatory inspections.

Full job description available during formal interview process.

What Sets GRAM Apart from Other Employers:

MEDICAL BENEFITS starting day 1: Blue Cross Blue Shield medical and dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying for 75% 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.

If you meet the required criteria listed above, GRAM welcomes you to apply today!