• Top Technical skills needed: Audit Preparation Experience, Compliance knowledge and Regulations, Lead Compliance gaps and remediation activities. Preferred / Optional CQA or qualified auditor for doing internal audits.
• Option for role to be extended or going perm: No
• Will they need to enter clean room? Yes
• Hours: Mon-Fri regular
• Any overtime, if yes how many hours: None expected
Quality Associate II
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 and Responsibilities: This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work. 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 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 accommodations 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.
Education and/or Experience: 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.