Quality Assurance Specialist (1st Shift, Wed. to Sun.)

Changing lives. Building Careers.

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes.

JOB DESCRIPTION

The Specialist, Quality Assurance (QA) is responsible for batch record release, donor record/batch record quality reviews, all quality record reviews, quality record filing/retention/records room, assist with document control, training records, Tracing Cards, all log maintenance, data entry, auditing, and investigations. The Specialist, QA is responsible for quality assurance metrics and maintaining all quality records/batch records in a secure and controlled manner. The Specialist, QA will ensure only safe tissue is released to finished goods for final distribution. The position will ensure compliance with applicable FDA, AATB, ISO, State regulations/requirements and Integra LifeSciences standard operating procedures.

This role is 1st Shift on Wednesday thru Sunday, off on Monday and Tuesday

RESPONSIBILITIES

• Ensure batches are released safely to finished goods for final distribution

• Perform batch record review and release for all human tissue product lots

• Review and approval of all quality records

• Perform quality reviews of donor and batch records

• Review and analyze test reports.

• Assist in audits and inspections.

• Log production lots into database.

• Order supplies for quality records and data management

• Assist with CAPA/NC/Deviation/SCAR/Complaint investigations and documentation

• Maintain databases and logs for all required departmental information

• Ensure all labeling and packaging of tissue product is performed

• Maintain all quality records in a controlled and secured location

• Initiate Non-conformances and participate in investigations as needed

• Create/revise Standard Operating Procedures and Forms as needed

• Maintain up to date knowledge with respect to relevant state-of-the-art technology, equipment, and/or systems

• Assist in Quality Control activities as directed by Supervisor

• Monitor trends on quality related activities and prepare graphs as needed by management

• Retrieve/send Quality related emails/deliveries/mail/faxes as applicable

• Perform any other related duties as assigned and needed

REQUIRED SKILLS & KNOWLEDGE

• BS degree in a scientific discipline (Chemistry, Biology, Physics, Bio-Medical Engineering/Chemical Engineering, etc.) with at least 1 year of QA experience or a High School diploma with at least 4 years of experience in quality assurance in a regulated industry.

• Able to work a 1st shift role Wednesday to Sunday

• Excellent attention to detail and record keeping.

• Proficient in Microsoft word, Excel and Power Point

• Knowledge of AATB Standards for Tissue Banking; preferred

• Organized, attention to detail and maintain appropriate analytical skills.

• Excellent communication skills, both written and verbal.

• Excellent organization, prioritization and problem-solving skills

• Able to lift 40 lbs.

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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