Description

Quality, Service, Collaboration, Courage. Do you exhibit these values and wish to be around others that do too? Are you interested in making a difference in your community and the world? Are you looking for a place where you can grow and learn in a diverse, community-minded culture? 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 II 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 including, but not limited to, conducting supplier audits, authoring annual product review reports, conducting internal audits, supporting client audits, supporting external regulatory audits (e.g. FDA, EU), writing effective audit reports, following up on audit responses and commitments (both internal and external), and oversight and enforcement of GMP regulations.

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.
• Strong communication and interpersonal skills to communicate professionally internally and with clients and regulatory agencies.
• Ability to work in fast paced environment, with multiple external clients.
• Proficient computer skills in Microsoft Word, Excel, and Outlook.

Preferred Requirements:

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

Responsibilities Include (but are not limited to):

• Support quality systems including Regulatory Surveillance, Annual Product Reviews, Controlled Substance Program, customer complaints, internal audits, and external audits
• Supports work such as Performing internal and external audits per approved schedules; Support continuous improvement efforts by issuing audit observations in a clear and collaborative manner, working with auditees as necessary to capture responses and action plans; Prepare summaries of internal and external audit findings for senior leadership; Maintaining and approving GRAM's third party provider lists and audit schedules; Collaborate with other departments to uphold provider requalification requirements; Assisting with preparation, review and drafting of annual product reviews and complaints where requested.
• Actively support 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 17 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: We offer all employees one (1) paid day of Wellness Time Off (WTO) per quarter to invest in self-care, take some downtime, or whatever 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.