About this role
Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
Job Description
Purpose
The Quality Systems Associate Specialist 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. This 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.
Additional Qualifications/Responsibilities
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.
Pay Range
$ 65500 - 125500 USD