Quality Associate II
Round Lake, IL
Req ID 51086BR
Business Title
Quality Associate II
Business
Medical Products
Sub-Business
Research and Development
Country
US
State/Province
Illinois
Location of Position
Round Lake, IL
Shift_
1st
Job Description
•Coordinate and execute cGMP stability studies. Participate in the development of stability study protocols for new pharmaceutical products and existing products with speed, accuracy, and consistency to meet quality drug development goals.
•Coordinate activities of outside work groups and monitor stability study progress to ensure timely and effective completion. Responsible for preparing Stability updates and Annual Reports to FDA.
•Participate on project teams and/or interact with various functions within Baxter in order to provide technical support and assistance. Proactively provide guidance regarding study set-up specifications, processes and timelines.
•Maintain knowledge of relevant Quality System Regulations, high level of expertise in current regulatory requirements and technical issues. as related to R&D (product development, design and safety) to ensure compliance in all research, data collection and reporting activities. Be an active participant in the generation, review, adoption and interpretation of such regulations.
•Aid in exploring innovative approaches to processes and technologies. Responsible for identifying improvements in metrics and lead process improvements.
•Maintain and own internal documents. Write, revise and review SOP's. Perform/assist in internal assessments by collecting and analyzing accurate, objective evidence regarding quality risks and their magnitude.
•Assist in training less experienced staff as needed. Assists and writes requirements for product changes and computer systems.
Job Requirements
•Exceptional organizational skills and ability to plan and implement resolutions to technical problems.
•Familiarity with auditing techniques, change control processes, interpreting regulations and quality systems.
•Understand scientific strategies and be able to invent new methods or new avenues of investigation.
•Employ appropriate techniques/methods (i.e. attention to detail, careful review, able to multi-task) to successfully and independently execute routine assignments within negotiated deadlines.
•Working knowledge of FDA Regulations, Application of Good Laboratory Practices, Application of Good Manufacturing Practices.
•Proficient in Computer systems and applications (e.g. LIMS, Excel).
•Good interpersonal/communication/influencing/negation skills. Good project management skills.
• Bachelor's degree in the sciences or in engineering with 3-5 years experience in Quality or related field in industry.
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
