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Quality Assurance Associate

Quality Assurance Associate

ActalentGrand Rapids, Michigan, USA
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Job Title : Quality Assurance Associate

Job Description

The Regulatory Affairs Specialist / Compliance Specialist / QA Specialist plays a crucial role in overseeing regulatory affairs activities for a contract development and manufacturing organization (CDMO). This position is integral to supporting regulatory needs for sterile injectable products, spanning from clinical through commercial phases. The Specialist will manage a wide array of projects, interacting with all internal departments, external clients, suppliers, contractors, and regulatory agencies. Please note, this role is not remote.

Responsibilities

  • Maintain current knowledge of all relevant regulations and monitor changes impacting product manufacturing.
  • Communicate regulatory requirements to stakeholders to ensure compliance.
  • Provide regulatory CMC support and review client submissions to align with supply agreements.
  • Submit and maintain letters of authorizations for client Type V Drug Master File submissions.
  • Manage FDA establishment registrations and product listings, including filing and obtaining new registrations.
  • Generate and maintain NDC codes for FDA approved commercial products for Cares Act Reporting.
  • Facilitate quality agreements with clients, ensuring alignment with regulatory requirements.
  • Submit annual GDUFA self-identifications to FDA.
  • Maintain and update the Type V Drug Master File, including amendments and annual reports.
  • Oversee the maintenance of Site Master Files for facilities.
  • Support business development due diligence evaluations and contribute to new-business selections.
  • Develop and maintain SOPs, work instructions, and related documentation for Regulatory Affairs.
  • Perform Regulatory Assessments for the holistic change control process.
  • Write, revise, and review departmental SOPs and associated documents.
  • Support agency, customer, and vendor audits as required.

Essential Skills

  • Bachelor’s degree in Life Sciences or related field.
  • 5+ years of experience in a regulated pharmaceutical / medical device industry.
  • Hands-on experience in Regulatory Affairs with growing responsibilities.
  • Working knowledge of regulatory requirements (FDA / ICH regulations, GDUFA).
  • Familiarity with regulatory submissions for INDs, ANDAs, NDAs, and DMFs.
  • Knowledgeable in regulatory science and submission data requirements.
  • Understanding of cGMP, ICH, and USP regulations or guidelines.
  • Excellent technical writing skills.
  • Experience in preparing FDA correspondence.

    • Additional Skills & Qualifications

  • Experience with regulatory submissions and post-approval supplements.
  • Knowledge of sterile parenteral product development phases.

    • Work Environment

    This position is based in an office environment.

    Pay and Benefits

    The pay range for this position is $40.00 - $52.00 / hr.

    Eligibility requirements apply to some benefits and may depend on your job

    classification and length of employment. Benefits are subject to change and may be

    subject to specific elections, plan, or program terms. If eligible, the benefits

    available for this temporary role may include the following :

  • Medical, dental & vision
  • Critical Illness, Accident, and Hospital
  • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
  • Life Insurance (Voluntary Life & AD&D for the employee and dependents)
  • Short and long-term disability
  • Health Spending Account (HSA)
  • Transportation benefits
  • Employee Assistance Program
  • Time Off / Leave (PTO, Vacation or Sick Leave)

    • Workplace Type

    This is a fully onsite position in Grand Rapids,MI.

    Application Deadline

    This position is anticipated to close on Sep 9, 2025.

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    Quality Assurance Associate • Grand Rapids, Michigan, USA