QUALITY ASSURANCE MANAGER – ASEPTIC OPERATIONS

Grand River Aseptic Manufacturing Located in: Grand Rapids, MI,  Midwest
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JOB DESCRIPTION

Provides direction and leadership to the Grand River Aseptic Manufacturing (GRAM) Quality Systems with oversight of Aseptic Manufacturing (formulation and filling) operations.  This position works closely with all levels of the Operations (Manufacturing and Finishing), Technical Services, Validation, QC (Microbiology and Analytical Chemistry), Business and Finance teams.

Responsibilites

  • Provide leadership to Quality Specialists of various levels. Responsibilities include hiring, managing, motivating, coaching and mentoring.
  • Ensure Quality support and oversight of Aseptic Manufacturing operations across all shifts, including occasional weekend support.
  • Oversight and management of the batch record review / in-process release processes
  • Review, assessment and approval of non-conformance reports, including deviations, laboratory / OOS investigations and environmental investigations.
  • Ownership of the Corrective / Preventive Action (CAPA) system.
  • Client support / interaction related to these processes.
  • Interface with auditors, including client representatives and regulatory agencies.
  • Perform Quality Assurance review and approval of cGMP documentation in support of continuous improvements, including:
    • Procedures
    • Test Methods
    • Master Batch Records
    • Risk Assessment Reports
  • Support Agency, customer and vendor audits as needed.
  • Exhibit professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
  • Perform all other tasks, projects, and duties as assigned.

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CRITICAL REQUIREMENTS

  • Qualifications • Bachelor’s Degree in Life Sciences or a related field • 6-8 years related work experience • 2 years of prior management / leadership experience • experience interacting with regulatory authorities (preferred) Skills • A thorough understanding of cGMP, FDA guidelines and multinational regulatory standards is required; experience and expertise in aseptic manufacturing of regulated products is preferred. • Ability to interpret and relate Quality standards for implementation and review. • Knowledge of Quality principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment. • Ability to portray an appropriate level of integrity and professionalism at all times. • Ability to communicate effectively with management, staff, regulators and client representatives, in both written and verbal forms. • Ability to complete tasks accurately and according to established timelines. • Demonstrated management ability with a proven track record of leading teams to meet objectives. • Ability to make sound decisions about scheduling, allocation of resources and managing priorities. • Proficiency in both written and verbal communication and presentations • Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment • Results oriented and efficient • Creative and open-minded who fosters an environment in which sharing of ideas is encouraged • Ability to work closely with a diverse customer base (internally and externally) • Ability to work well in a cross-functional team environment • Must have proficient computer skills in Microsoft Word, Excel and Outlook  

COMPANY INFORMATION

Today, the market for parenteral manufacturing services is growing rapidly primarily due to the number of new biologics in development. These innovative products require a partner that understands the complexities of these therapeutics and has the experience, facilities and flawless quality record to meet your timelines. Grand River Aseptic Manufacturing was founded in 2010 as a joint venture between the Van Andel Institute and Grand Valley State University. Our company supports the life sciences industry’s growing need for high-quality, outsourced sterile parenteral manufacturing. We are privately held, with more than 100 employees in two locations near downtown Grand Rapids, Michigan. With nearly 40,000 square feet of sophisticated cGMP space, GRAM meets a full range of fill/finish needs, from early clinical fills through commercialization. All our equipment and processes are fully qualified and validated to ensure cGMP compliance.

JOB INFORMATION

Seniority Level:
Management / Supervisory
Function:
  Quality
Preferred Industry Background:
  Pharmaceuticals
Managing a team of:
6 employees
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation:
Education Required:
Undergraduate
Generic vs. Branded:
Both Equally
OTC vs. RX:
RX