Quality Associate II

Job Title: Quality Associate II
Job Location: Round Lake, IL 60073
Job Duration: 12 Months+ (Possibilities of Extension)
 
Shift: Work shift – Std
Pay Range: $31.0 - $33/hr. on W2
 
Job Description:

• This section focuses on the main purpose of the job in one to four sentences.
• 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.

• 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.

• 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.