QA Specialist - Client and Project Support

Grand River Aseptic Manufacturing Located in: Grand Rapids,  Michigan, Midwest
(Private and Secure - Guaranteed!)

Grand River Aseptic Manufacturing Biotechnology Jobs Pharmaceutical Careers
 

JOB DESCRIPTION

Performing Quality Assurance review and approval of all cGMP documentation in support of both GRAM and client-driven projects, including:

Raw Material, Component and Finished Product Specifications

Test Methods

Master Batch Records

Risk Assessments

Validation Documents including Analytical and Microbiology Test Method Validation, Equipment Qualification (IQ, OQ, PQ), PPQ, URS, FRS, etc.

Working as the QA representative on project teams to ensure that project deliverables meet all regulatory and industry best practice standards.

Perform all job responsibilities in compliance with cGMPs, company SOPs, and current industry practice.

Provide back-up support for the review and approval of Quality Assurance required signatures for controlled documentation.

Open to a flexible and fluid work environment.Work on any assignment as directed.

Project a positive and professional image of the GRAM and self by providing quality services to all internal and external customers.

Perform all other tasks, projects, and duties as assigned.

CRITICAL REQUIREMENTS

  • Knowledge of QA principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment

    Must have strong interpersonal skills, be a team player, have strong customer focus with a drive to exceed expectations

    Ability to complete tasks with accuracy and efficiency

    Portrays appropriate levels of integrity and professionalism

    Excellent written and verbal skills

     

    This level of knowledge is normally acquired through completion of a Bachelor’s Degree in Life Sciences or a related field and/or a minimum of 3-5 years related work experience.

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:
Experienced - Not Management
Function:
  Quality,  Project Management
Preferred Industry Background:
  Pharmaceuticals,  Biotechnology
Managing a team of:
N/A
Required Travel:
Not at all

Base Salary:
Confidential
Bonus:
Benefits:
Competitive Salary Health, Dental, Vision Life Short-Term Disability Long-Term Disability 401(k
Other Compensation:
Education Required:
Any