Quality Systems Specialist - Katalyst Healthcares & Life Sciences
Lake Forest, IL 60035
About the Job
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 with 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.
- Specialist Quality Systems is responsible for providing quality assurance support for some or all 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.
- This position will ensure that all products, process or system related quality activities from raw material inspection through shipment of final product are following Corporate and governmental regulations.
- 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 teams 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.
- Bachelor's Degree 3+ years' experience in quality assurance, quality oversight or relevant experience.
- Quality mindset.
- MS Office (Excel-average experience).
- Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products preferred.
- Strong oral and written communication skills needed.
- Experience working in both teams setting and independently.
- Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
- Bachelor's degree in chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred.
- Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products preferred.
Source : Katalyst Healthcares & Life Sciences
