Now Hiring an QA Specialist

Pay: $35hr - $42hr

Location: Must be local to the state of Minnesota

Job Description:

QA Specialist will have a good understanding of GMP regulations and be able to identify and resolve quality issues with consultation with Quality management. This individual will independently review and approve Blood Product documents to assure identity, safety, quality, and purity of the blood product. The individual will monitor production and laboratory operations to ensure compliance to cGMPs and Blood Product procedures.

Key Responsibilities:

• Maintain and support SAP material release processes and validation requirements.

• QA Support of computerized systems (SAP, Compliance wire, Blood Establishment Computer software(BECS).

• Maintain and support required quality activities and programs for Blood Products.

• Monitor production and laboratory operations to ensure compliance to cGMPs and Blood Product procedures

• Independently performs Quality review and approval of Blood Product documents, such as Policies, Standard Operating Procedures, Work Instructions, Procedures, Plans, Study Protocols/Reports, Specifications and Forms

• Independently performs Quality review and approve change orders, investigations, non-conrfoming events, CAPAs and other associated activities

• Identifies and resolves quality issues using problem-solving skills, in consultation with management and other cross functional departments.

• Create and revise QMS procedures as needed

• Identify and implement changes to the Blood Products Quality programs to improve effectiveness and efficiency

Skills & Qualifications:

• 3-5 of GMP quality experience utilizing quality systems within pharmaceutical or medical device industry

• Knowledge of Blood Products

• Good understanding of FDA Guidance\'s for Industry

• Proficiency with MS Office programs

• Good organizational skills

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.