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:
Application Question(s):
- Only open for US Citizens and Green Card Holders.
Education:
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