Quality Assurance Specialist - Tucson, United States - The Cooper Companies

The Cooper Companies

Verified Company

Tucson, United States

1 week ago

Posted by:

Mark Lane

beBee recruiter

Description

About CooperSurgical

CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life.

CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families.

We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.

The Life Science Quality Assurance Specialist II is a mid-level position reporting to the Life Science Quality Manager and/or Supervisor.

The role will be the point of contact for inquiry, collaboration, and maintenance of the Quality Management System. The individual will have the opportunity to learn and mentor Quality team members. The Specialist will collaborate and help Quality Assurance customers identify root cause and risk remediation. As a Specialist II, the individual will maintain and ensure compliance to Quality System programs.

Bachelor's degree (BA) from fouryear college or university or Associates degree (A.A.) with three to five years related experience and/or training.
OR four to six years related experience and/or training; or equivalent combination of education and experience.
Understands and applies comprehensive knowledge of quality principles and maintains current understanding of regulations.
Familiarity or experience with the following is strongly preferred: Basic statistics, review/approval of documentation; risk tools, technical writing, and writing/reviewing/approving investigations.
Knowledge of Master Control, or similar eQMS a plus
Canidates must show knowledge and proficiency in the Quality Assurance Specialist I role

CLIA (42 CFR 493), FDA (21 CFR 820); Industry standards: ISO 15189 Medical Laboratories

AABB, AATB, FACT, FDA (HCT/P, cGMP, cGTP), 21CFR 1271, Health Canada and ISO regulations

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status.

We are proud to be an equal opportunity workplace.

Provide Quality oversight and support as needed by Quality customers.

-
Support and partake in Quality Management System Processes such as:

Document Control Program:
review, approval, and maintenance of company Standard Operating Procedure via electronic Document Quality Management System. Ensuring stakeholders are adhering to company policies and templates.

Change Management Program:
Review, approve and track changes to approved procedures, validated software and processes, qualified equipment. Review the change task completion. Track and facilitate investigation in cross functional impacted teal to support closure of Change Control.

Deviations and Nonconformances:
Review, approve and monitor the events and deviations. Complaint handling and investigations Track and facilitate investigation in cross functional team discussions in support of closing Quality Events

Supply/ Vendor Management:
Supplier qualification, reassessment activities, quality agreements, quality score cards. Oversee the process is maintained and approved according to processes.

Validations:
Review and approval of equipment, systems validation/ qualification, and any design transfer to operations

Quality Metrics:
Perform trending analysis and reporting of quality indicators. Identification or risk and process improvements into operations.

Reviews chart and medical records for completeness of all required testing and documents for various processes.

Compliance:
Audit plan and reporting to applicable standards. Review and approval of corrective action and supporting evidence. Aid in audit hosting and preparation. aid in tracking and trending of internal and external findings, investigation and implementation of corrective/ preventive measures.

Perform data entry, data analysis, tracking, trending, creating graphs and reports as required for each Quality Management System modules monitoring timeliness and effectiveness.
Perform compliance review on executed records from completeness of all required testing and documents for various processes.
Maintain understanding of root cause analysis techniques to help quality customers with investigation of complex matters on root cause analysis techniques and processes.
Identification of risk and risk mitigation
Work cooperatively in a team environment to maintain cross functional, and cross site processes and procedural consistency for quality systems records.
Recognizes errors in records and resolves them in a timely manner.
Perform other Quality Assurance Duties as required.

LL-DD1