Job Description:
Purpose:

• The Specialist Quality Systems is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, combination products and biologics. Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training and CAPA.
• position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.

Responsibilities:

• Assist with proper integration and support of quality regulations: drug, biologics, device and/or combination products.
• Assist project teams in planning, preparation, review and approval of quality documentation.
• Complete and route change requests for process document creation, maintenance, and implementation.
• Create quality system documentation and specifications with guidance from technical teams following approved templates and guidelines.
• Assist with or co-lead audits of documentation, facilities and equipment.
• Assist in the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system.
• Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.
• Participate in training and education programs for various aspects of quality assurance.

Qualifications:

• Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred.
• 3 years' experience in quality assurance, quality oversight or relevant experience.
• Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations.
• Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products preferred.
• Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products preferred.
• Experience working in both team setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
• Strong oral and written communication skills needed.
• Excellent interpersonal skills a plus.
• Runs small projects to deliver tactical results.

Job Types: Full-time, Contract

Pay: $50.12 per hour

Expected hours: 40 per week

Schedule:

• 8 hour shift

Application Question(s):

• Only open for US Citizens and Green Card Holders.

Education:

• Bachelor's (Preferred)

Experience:

• Medical devices: 3 years (Required)
• GMP: 4 years (Required)
• CGMP: 4 years (Required)
• Quality assurance: 5 years (Required)
• Quality control: 5 years (Required)
• Quality systems: 3 years (Required)

Ability to Relocate:

• North Chicago, IL: Relocate before starting work (Required)

Work Location: On the road