Quality Associate II

3 months ago

Skaneateles, United States Katalyst Healthcares & Life Sciences Full time
Responsibilities Requirements:
  • As a Corrective and Preventive Action (CAPA) Quality Specialist, the ideal person will manage and continuously improve the CAPA program.
  • You will own and facilitate root cause analysis activities, review all phases (investigations, action planning, verification of effectiveness, etc.) of CAPAs owned by others, and provide/request/present CAPA record information to ensure complete and thorough CAPAs.
  • Responsible for providing Quality support and oversight via direct staff supervision or process/area responsibilities.
  • Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and quality practices Essential Duties.
  • The incumbent will perform other duties assigned.
  • Leads ongoing, daily departmental operations.
  • May include the supervision of assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner; Interview/hire, evaluate, train and develop direct reports Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude.
  • Assessments and information gathering may be done through in-depth employee interviews, flow charting and other informational gathering techniques. Work closely with production supervisors, quality, engineering and other internal groups to accomplish the above and influence necessary actions.
  • Determine the logic, adequacy and effectiveness of processes, systems and related requirements.
  • Develop plans to correct identified risks including areas of non-conformance. Inform management and implement approved corrective action plans. Serve as Subject Matter Expert (SME) by maintaining a high level of expertise in current regulatory requirements.
  • Provide training and coaching to local employees and others as needed on relevant area(s).
  • When required, assist other Quality areas in the successful performance of these activities.
  • Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
  • Participate in external assessments and audits by evaluating and solving product/process problems by providing technical, analytical and supervisory skills Support process with timely closure of observations/audit items.
  • Oversees audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.) Participate in QA/QC multi-site projects in the role of contributor, coordinator or lead. Other duties, tasks or projects as assigned.
  • Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
  • List knowledge, skills, and/or abilities required. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.
  • Strong interpersonal skills and great attention to detail are necessary.
  • Must be a strong team player with good problem solving, and good verbal and written communication skills. Must have the ability to manage people, encourage teamwork and drive decisions.
  • Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
  • Include the education and experience that is necessary to perform the job satisfactorily. BS in business/science or equivalent. 3-5 years exp. in Quality with a medical.

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