Quality Assurance Specialist (Documentation/Investigation/CAPA)

The Quality Associate supports the Quality Function that they are responsible for within Operations.This could include: Incoming Quality Assurance of drugs and packaging materials, Manufacturing Quality Assurance, Validation, Quality Engineering, Training and Regulatory Compliance.Expectations that the Quality Associate will maintain high quality levels on all aspects of their job while achieving high levels of efficiency. Responsibilities :Responsible for various aspects of quality assurance and quality control related to their functional area.Ensures that product within the plant is consistently manufactured in conformance with company Quality System requirements and all applicable regulatory requirements.Support troubleshooting and resolution of quality compliance issues.Communicates with Management for Quality Management Review, Quality Initiatives, etc.Incumbent is responsible for quality decisions related to their functional area to ensure compliance with company Quality Systems and cGMPs.Qualifications :Must be familiar with use of electronic document management and laboratory information management.Must also be familiar with Quality Systems as well as cGMP and other regulatory requirements.Strong communication skills, both oral and writtenAre you open to look at candidates willing to relocate? n/a

Years of experience/education and/or certifications required:Bachelor’s Degree/ 2+ years of combined experience in Manufacturing, QA, QC, R&D in pharmaceutical or biologics industryWhat are the top 3-5 skills requirements should this person have?Whether it is through manufacturing or quality control, a certain level of quality experience is necessary.some form of review experience: data or record review1+ years within a manufacturing facilityWhat is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?Bonus: some work with investigationsBonus: experience with document revisionsBonus: review of GMP commercial batch recordsDaily Work Schedule Expectations Monday to Friday 9-5 or 10-6 is ideal