- 203034 - Quality Associate III
- 12 months
- Chipton-Ross is seeking a Quality Associate III for a contract opportunity in Milwaukee, WI.
This position is 100% onsite.
This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned. · Lead ongoing daily departmental activities for areas of direct responsibility including supervision of assigned personnel, and when required assist other Quality areas in the successful performance of these activities.
· Manage activities of self and direct reports in achieving defined quality goals in an efficient, accurate and timely manner.
· Be directly involved in and where appropriate lead multiple process/product improvement projects which may include any of the following - PMT, QWT, Kaizan, or other focus groups, design of experiments, validations, development of new methodologies and improving existing methodologies, data generation, report development and presentation.
· Lead in-plant audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO and quality requirements. Maintain a high level of expertise in current regulatory requirements, and serve as a plant resource for compliance to these requirements
· Lead in the development of customer awareness and understanding activities for areas of direct responsibility, and where appropriate, assist and support such activities throughout the facility.
· Provide guidance and coaching for the areas of responsibility as defined in items # 1 through #5 for less experienced individuals within the plant.
· Must be a recognized by all levels of the facility as an expert in their area and be able to demonstrate leadership ability.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Understand scientific strategies and be able to invent new methods or new avenues of investigation. Good interpersonal/communication/influencing/negation skills.
Must have the ability to perform the responsibilities of the Quality Section Manager on an as needed basis. Assists and writes validations for equipment, product changes and computer systems.
· Assists with vendor audits/assessments and provides ongoing feedback related to quality issues.
· Good project management skills · Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
Accredited Bachelor's degree in science or engineering; advanced degree in the life sciences, physical sciences or engineering, with Ph.D. is ideal. Lead Auditor training, ISO Lead Assessor training, with 2-3 years experience in auditing techniques, interpreting regulations and quality systems. Minimum of 5-8 years of experience in Quality, or related field in the medical products industry.
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x307 or (800) 927-9318 x307
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.