Planet Pharma
Overview
Job title: Quality Assurance (as described in the original posting). Location: Arlington Heights, IL / Round Lake, IL / Northbrook, IL, etc. Salary ranges vary by position. This section has been cleaned to reflect responsibilities and qualifications for the role. Responsibilities
Leads ongoing, daily departmental operations and may supervise assigned personnel to achieve 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. Gather information through interviews, flow charting and other methods; work with production supervisors, quality, engineering and other internal groups to drive corrective 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 on relevant areas as needed. Assist other Quality areas as required; write, review, analyze and revise SOPs to meet corporate, divisional, plant and regulatory requirements. Participate in external assessments and audits; evaluate and solve product/process problems with technical, analytical and supervisory skills. Support processes with timely closure of observations/audit items; oversee audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.). Participate in QA/QC multi-site projects as contributor, coordinator or lead; perform other duties and projects as assigned. Qualifications
Strong interpersonal skills and meticulous attention to detail; able to work effectively as part of a team and communicate clearly (verbal and written). Ability to manage people, encourage teamwork and drive decisions; capable of handling multiple projects concurrently. Computer proficiency; knowledge of FDA Regulations, Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP). Education And/or Experience
BS in business/science or equivalent; 3-5 years of experience in Quality with a medical focus. Job Function
Quality Assurance Industries
Staffing and Recruiting Seniority level
Not Applicable Employment type
Full-time Benefits and Notes
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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Job title: Quality Assurance (as described in the original posting). Location: Arlington Heights, IL / Round Lake, IL / Northbrook, IL, etc. Salary ranges vary by position. This section has been cleaned to reflect responsibilities and qualifications for the role. Responsibilities
Leads ongoing, daily departmental operations and may supervise assigned personnel to achieve 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. Gather information through interviews, flow charting and other methods; work with production supervisors, quality, engineering and other internal groups to drive corrective 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 on relevant areas as needed. Assist other Quality areas as required; write, review, analyze and revise SOPs to meet corporate, divisional, plant and regulatory requirements. Participate in external assessments and audits; evaluate and solve product/process problems with technical, analytical and supervisory skills. Support processes with timely closure of observations/audit items; oversee audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.). Participate in QA/QC multi-site projects as contributor, coordinator or lead; perform other duties and projects as assigned. Qualifications
Strong interpersonal skills and meticulous attention to detail; able to work effectively as part of a team and communicate clearly (verbal and written). Ability to manage people, encourage teamwork and drive decisions; capable of handling multiple projects concurrently. Computer proficiency; knowledge of FDA Regulations, Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP). Education And/or Experience
BS in business/science or equivalent; 3-5 years of experience in Quality with a medical focus. Job Function
Quality Assurance Industries
Staffing and Recruiting Seniority level
Not Applicable Employment type
Full-time Benefits and Notes
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
#J-18808-Ljbffr