Job Title: Quality Specialist

Job Description

The QA Specialist will have a good understanding of GMP regulations and be able to identify and resolve quality issues in consultation with Quality Management. This individual will independently review and approve product documents to assure identity, safety, quality, and purity of the product. The specialist will monitor production and laboratory operations to ensure compliance with cGMPs and procedures. This role supports project activities, reviews and approves NCEs and CAPAs, addresses product complaints, handles Field Alerts, Biological Product Deviation Reporting, Recalls, and other quality-related activities for Blood Products.

Responsibilities

• Review and approve NCEs/CAPAs to prevent recurrence of issues.
• Hold cross-functional meetings and update procedures.
• Improve processes and maintain, coordinate, monitor, and continually improve quality activities/programs related to blood products.
• Support SAP material release processes and validation requirements.
• Provide QA support of computerized systems including SAP, ComplianceWire, and Blood Establishment Computer Software (BECS).
• Ensure compliance with cGMPs and Blood Product procedures in production and laboratory operations.
• Independently review and approve Blood Product documents including Policies, SOPs, Work Instructions, Procedures, Plans, Study Protocols/Reports, Specifications, and Forms.
• Review and approve change orders, investigations, non-conforming events, CAPAs, and other associated activities.
• Identify and resolve quality issues using problem-solving skills.
• Create and revise QMS procedures as needed.
• Implement changes to Blood Products Quality programs to improve effectiveness and efficiency.
• Communicate with directors and stakeholders to ensure communication of outcomes.
• Participate in on-site Regulatory Inspections.
• Provide metrics and data-driven solutions to reduce cost of quality and improve monitoring system efficiency for blood products.
• Assist with complaint investigations, Field Alerts, Biological Product Deviation Reports, and Recalls.
• Evaluate and trend Blood Product QMS activities/programs for Management Review.
• Ensure appropriate document management and product disposition.
• Write and edit procedural documentation such as Operating Procedures, batch records, and test methods.
• Meet with Operation engineers, Regulatory, and project managers to learn about specific products or processes.

Essential Skills

• Quality assurance
• Agile
• SOP
• Nonconformance events
• Compliance
• Auditing
• 3-5 years of relevant Quality experience in pharmaceutical or medical device industry
• Experience and/or knowledge of pharmaceutical or medical device industry regulations
• Ability to work independently with limited supervision
• Good listening, verbal, and written communication skills
• Effective presentation skills for staff and department meetings
• Excellent interpersonal skills and ability to work in a team environment
• Ability to prioritize and adapt to shifting priorities
• Knowledge of FDA regulations

Additional Skills & Qualifications

• Maintain and support SAP material release processes and validation requirements
• QA support of computerized systems such as SAP, ComplianceWire, and BECS
• Experience in monitoring production and laboratory operations for compliance
• Ability to perform Quality review and approval of Blood Product documents independently
• Experience in reviewing and approving change orders, investigations, non-conforming events, and CAPAs
• Problem-solving skills for identifying and resolving quality issues
• Experience in creating and revising QMS procedures
• Ability to implement changes to improve effectiveness and efficiency of quality programs
• Experience in participating in on-site Regulatory Inspections
• Ability to provide metrics and data-driven solutions to reduce cost of quality
• Experience in assisting with complaint investigations, Field Alerts, Biological Product Deviation Reports, and Recalls
• Ability to evaluate and trend QMS activities for Management Review
• Experience in ensuring appropriate document management and product disposition
• Skill in writing and editing procedural documentation
• Ability to collaborate with Operation engineers, Regulatory, and project managers

Pay and Benefits

The pay range for this position is $35.00 - $42.23/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 Maple Grove,MN.

Application Deadline

This position is anticipated to close on Apr 8, 2025.

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 for other accommodation options.

Salary : $35 - $42