Quality Assoc III
Westlake Village, CA
Req ID 50368BR
Business Title
Quality Assoc III
Business
Global Quality
Sub-Business
BioScience Support
Country
US
State/Province
California
Location of Position
Westlake Village, CA
Shift_
1st
Job Description
1. Act as quality representative on product development projects with emphasis on defining quality requirements, design control, design verification & validation, risk management, and quality systems implementation.
2. Development and maintenance of intermediates, API, final products and process specifications ( including LIMS activities)
3. Preparation/ support for preparation of specifications for raw materials
4. Lead for preparation of chemistry, manufacturing, control (CMC) and related quality documentation for submission purposes and respective approval of documents
5. Ownership of technical documentation and Design History Files for products
6. Maintenance of quality control documentation with respect to guidelines, authority requests, pharmacopoeias, and normative documents
7. Participation in meetings with Authorities, Quality lead in answering Authority questions with regard to CMC Section of Dossiers
8. Quality Core Team member in PDP and R&D projects, assurance of Compliance
9. Implementation of Design Control as an interface between R & D, Process Development, Preclinical and Clinical, Manufacturing and the Project Portfolio Management Group for developmental products
10. Design and Reporting of Stability-Studies (including LIMS activities)
11. Scientific support for product related Exception Management, Change Controls, investigations, CAPAs, Validations, etc.
12. Quality approval of pre-clinical CoAs
13. Leading/participating internal and external audits
14. Review of Development Reports/Technical Reports
15. Organization of external laboratories for QC-tests
Job Requirements
qualifications:
1. Effectiveness in team leadership, task completion, decision-making, training, and problem solving. A functional understanding regulatory requirements (US,EU,JP) and industry guidances (ISO, ICH) is required.
2. Good project management skills
3. Good computer skills, proficient writing, organization and presentation skills.
4. Good interpersonal/communication/influencing/negation skills.
5. Working knowledge of regulatory requirements (US, EU ,JP) and industry guidelines (ISO, ICH)
Bachelor or Masters' degree with minimum of 7+ years of experience in Quality, or related field in the medical products industry. Ph.D. with one or more years of postdoctoral experience preferred.
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.
