Quality Assoc III
Van Nuys, CA
Req ID 50358BR
Business Title
Quality Assoc III
Business
Global Quality
Sub-Business
BioScience Support
Country
US
State/Province
California
Location of Position
Van Nuys, CA
Shift_
1st
Job Description
•Manage activities of self and direct reports in achieving defined quality goals in an efficient, accurate, and timely manner. Prioritize and schedule work assignments as required to meet department goals.
•Write, revise, and review Standard Operating Procedures (SOPs) and ensure compliance with regulatory requirements, industry practices, and Baxter quality standards.
•Ensure Lookback/PDI Reference files are complete, accurate, maintained, and filed appropriately and meet all procedural requirements.
•Establish, prepare, and/or review trend data of various quality indicators and present trend data on a monthly and quarterly basis as required to management.
•Support internal or external assessments as required while ensuring timely closure of observation/audit items.
•Assist in training staff and assure training requirements are met and records are up to date. Provides guidance and development for staff to ensure proper succession planning.
•Must be recognized by all levels of the facility as an expert in their area and be able to demonstrate leadership ability.
•Must have the ability to perform the responsibilities of the PQR Manager on an as needed basis.
•Complete other tasks as assigned by management.
Job Requirements
•Strong knowledge of Microsoft Applications (Word, Excel, and Visio)
•Must be detail oriented and have strong organizational/ project management skills.
•Must demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership.
•Ability to prioritize staff workflow and handle multiple activities and meet deadlines.
•Knowledge of FDA Regulations and Good Manufacturing Practices as they apply to Source Plasma and Recovered Plasma.
•Ability to identify errors or faults in process and implement solutions.
•Must be sensitive to confidential information.
•Ability to diplomatically interact well with coworkers and staff.
•Good interpersonal/ communication/ influencing/ negotiation skills.
•Knowledgeable with computerized systems (e.g. APDS, TrackWise, JDE, etc.)
•Must be a team player.
•BA/BS degree in Business, Engineering, Science or related fields or comparable (10-15 years) industry experience. 3-5 years of experience in Plasma/Whole Blood Industry is highly desirable. Supervisory experience is required. Requires scientific and/or technical knowledge in the areas of manufacturing, laboratory testing, documentation and regulations.
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.
