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Quality Assurance Analyst I_US

  • Permanent
  • Anywhere

Website Mindlance

Mindlance

Company : Mindlance

Country: United States

Location : Cordova, Tennessee

Post: Fri, 24 Mar 2023 06:35:36 GMT

Expires: Fri, 21 Apr 2023 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

JOB DESCRIPTION

The Quality Assurance (QA) Specialist 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 QA Specialist is responsible for quality assurance metrics and maintaining all quality records/batch records in a secure and controlled manner. The QA Specialist 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 standard operating procedures.

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.

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.

RPM: F1 23 T01

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