Quality Assurance Senior Specialist

The Life Science Quality Assurance Specialist III is primarily responsible for establishing developing implementing maintaining and improving Quality System processes and programs to include Quality Event Reporting (Deviations Nonconformance Change Management CAPA Complaint) Document Control Program Supplier Qualification Validations and Product Transfer. In this role the candidate will mentor and train new personnel on the Quality System(s). The Quality Specialist III will partner with stakeholders to improve the quality program and quality culture within the organization. The candidate should have strong written and verbal communication skills to foster cross-functional collaboration and partnerships lead by positive influence maintain a high level of integrity and possess a strong continuous improvement mindset.

Essential Functions & Accountabilities:

• Maintains a culture of quality awareness teamwork and cooperation with Quality customers.
• Provide Quality oversight support and engagement as needed by Operations.
• Owner of Quality Management SystemProcesses 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 records for completeness of all required testing specifications 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.

• Facilitate meetings provide system visibility communicate status and facilitate closure of aging items.
• Gather performance metrics and coordinate Management review inputs from various contributing departments.
• Track trend and report Quality System metrics to ensure continuous quality improvements while communicating critical compliance and quality risks.
• Work cooperatively in a team environment to maintain cross functional and cross site processes and procedural consistency for quality systems records.
• Create and implement a training program for the QMS processes to educate Quality Assurance customers.
• Perform other Quality Assurance Duties as required.

#LI-DD1

• Bachelors degree (BA/BS) from four-year college or university or associate degree (A.A.) with four to six years related experience and/or training.
• OR six to eight years related experience and/or training.
• OR equivalent combination of education and experience.
• Knowledge of Master Control or similar eQMS a plus.
• Demonstrated experience and proficiency in Microsoft Office applications Word Excel and PowerPoint.
• Candidates must show knowledge and proficiency in the Quality Assurance Specialist II role.
• Candidate should demonstrate knowledge of regulations and standards such as:

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

AABB AATB FDA (HCT/P cGMP cGTP) 21CFR1271 FACT and ISO 9001 regulations