Quality Assurance Specialist (PM Start, Swing Shift)
ResponsibilitiesLocation Valencia, CaliforniaUS Job ID JR-023354
Imagine a world where you could detect health issues sooner to treat them more effectively. Where food and water are always safe, even in remote corners of the earth. And where scientific and medical research are enhanced to solve the greatest challenges of our times. At PerkinElmer, we imagine this world every day. Then, we innovate and collaborate to make it happen everywhere.
Our dedicated team of about 14,000 employees worldwide, pioneers scientific technologies for better detection, imaging, and informatics to help our customers work to create healthier families, improve the quality of life, and sustain the well-being and longevity of people globally.
If you are seeking a meaningful, impactful, and stimulating career, look no further.
PerkinElmer is seeing a Quality Assurance Specialist who will provide support to the Laboratory Director, Site Manager, and all supervisors on all quality related matters. This individual will develop and implement training and education programs, to educate workers and management on quality processes, standards, and results. This individual will also assist in facilitating quality meetings with pertinent site management. A strong candidate for this position will be able to maintain good rapport and communication with leadership and team members while ensuring solid execution of all quality programs.
Duties and Responsibilities:
Provide advice and support to the Laboratory Director, Site Manager, and Supervisors and teams on quality issues.
Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
Administrates Medialab Document Control System and ensure SOPs, Trainings and Policies are current versions and assigned appropriately. Notify Department leaders of employee signoffs not completed within deadlines.
Review all SOPs, validations, and incident reports to ensure they meet Quality standards and adhere to company guidelines.
Participate in the maintenance of laboratory licensure as required by CLIA and local regulations.
Quality assurance and control of laboratory performance through internal and external audits.
Training & Education: Assist with training and education programs, to educate employees and management on quality processes, standards, and results.
Project Management: Participate in the planning, initiation, and management of quality improvement projects.
Lead and implement various product and process improvement methodologies (e.g., Six Sigma).
Maintain good communication with leadership, team members and customers.
Represent quality decisions and practices in leadership, management, or review meetings with business leaders.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements Understand ergonomic relationship between people, equipment and working environment.
Familiarity with operation of laboratory instruments and applicable computer software.
Other duties as assigned.
Bachelor of Science degree in biological sciences/or clinical laboratory science or equivalent.
Minimum 2 years of experience in quality management or related clinical laboratory activities.
Experience with Quality Assurance, statistical Quality Control, and laboratory regulations/accreditation requirements required.
Previous experience of working in quality in clinical molecular biology or infectious disease testing labs as a Lab Technologist.
Knowledge of CLIA regulations and familiar with local regulations.
Partner and work collaboratively with laboratory operations staff.
Proven track record of delivering continual positive process improvement in systems and process.
Proven leadership and excellent organization and communication skills.
A good balance of negotiating and influencing skills.
Excellent presentation skills.
Be detail oriented, organized, with excellent verbal and written communication skills.
Able to work effectively and able to deliver on tight datelines.
Comfortable working in a fast-paced environment.
Clinical and research lab environment; exposure to blood borne pathogens; must wear personal protective equipment including lab coat, gloves and completely closed footwear.
Employee may be requested to work shifts other than daylight depending on the needs of the laboratory.
Weekend rotation may be required.
Travel is not required.
While performing the duties of this job, the employee is regularly required to sit, stand, use a keyboard, type, and occasionally stand and move to other parts of the lab.
Must have manual dexterity to use lab equipment.
Reach above/below the shoulder, bend at the knees and waist.
Able to lift boxes up to 25 pounds.
Paid Vacation, holiday and sick time
Medical, Dental, Vision Coverage
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities of this job at any time.
PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.
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