Pharma Quality Assurance

Collins Consulting, Inc

Waukegan, IL

Apply

JOB DETAILS

JOB TYPE

Full-time

LOCATION

Waukegan, IL

POSTED

30+ days ago

This is a hybrid position, local candidates only. Description: This individual will work in the Global Quality System & Strategic Transformation organization supporting global projects and initiatives. Activities include all aspects of project management for Drug Shortage Prevention Plans (DSPP), creation of deliverables, working with stakeholders and driving technical enhancements. The individual will directly work with the Global Quality Risk Management team and be responsible for establishing and maintaining records. DSPP work involves active collaboration with a cross-functional team in manufacturing sites, external manufacturing, regulatory, supply chain, product quality, compliance, and other global functions. This global function includes monitoring, tracking, and supporting various efforts and initiatives in the Quality System. Responsibilities: Lead meetings to facilitate and/or support the DSPP Project. Actively collaborate with a cross-functional team to complete project milestones and DSPPs per established timeline. Assist the functional areas on completing the DSPP risk factors and input in the DSPP. QA review of DSPP content in compliance with established governing documents. Oversee, monitor and track key deliverables associated with DSPP Implementation Project Metrics and related initiatives. Support other DSPP Project deliverables or initiatives as requested. Qualifications: Bachelors degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific area. Minimum of 5 years of experience in Quality Assurance and/or Quality System oversight. Risk Management, supply chain, compliance and drug shortages experience preferred. Lead meetings with technical professionals and experience in leading cross-functional teams with a results-orientated approach. Preferred: Knowledge of regulatory documents such as ICH, US / EU and other key GMP regulations. Skills: Result-oriented, strong oral and written communication skills, excellent interpersonal skills, initiative, attention to details, time management in a fast-paced environment, teamwork, problem solving and project management. Computer system skills including Microsoft Office; proficient in Power Point and Excel. What are the top 3-5 skills, experience or education required for this position: 1. Project Manager (Pharma) 2. Quality Assurance experience (Pharma); more than 5 years 3. Experience in Quality Risk Management, compliance, drug shortages

About the Company

Collins Consulting, Inc

Collins Consulting brings over two decades of total talent solutions experience to meet your on-demand consulting needs. We have an established history of serving clients nationwide in both the public and private industries. These clients range from Fortune 100 companies within the commercial arena to supporting contracts within federal agencies.

Collins Consulting is a certified Service-Disabled Veteran Owned Small Business and a SBA Small Business. We believe in servicing our country's veterans by supporting and nurturing opportunities to join their skillsets with clients who have the same principles. These certifications coupled with Top Secret facility clearance allow us to meet category and diversity goals.

Collins Consulting is agile, innovative, and an award winning advocate in providing total talent solutions to serve your business needs. Whether you are a professional who is looking for a new career or an organization in need of experienced talent, we have the resources to help you.

COMPANY SIZE

10 to 19 employees

INDUSTRY

Staffing/Employment Agencies

WEBSITE

http://www.colcon.com