Job Description

job summary:
As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you\'re looking for a position where you can serve as an asset to your company while making a difference in others\' lives, we have the ideal position for you!

location: Cordova, Tennessee
job type: Contract
salary: $20 - 23 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:
Quality Control (QC) Specialist - Inspection and Testing is a member of the Quality Department employed to ensure all human tissue, supplies, reagents, materials, etc. are inspected and approved for use prior to receipt and throughout key steps during the process. QC Specialist - Inspection & Testing will be responsible for performing inspections of incoming donor tissue, supplies, materials, and reagents, will control tissue while stored in Quarantine, ensure all required in-processed testing is performed and acceptable, ensure labeling and packaging is correct prior to release of product to finished goods. QC Specialist - Inspection & Testing will be responsible for ensuring our tissue and final tissue products are released in a timely and efficient manner. QC Specialist - Inspection & Testing will ensure full compliance with the Quality Management System (QMS) as required by 21 CFR Part 1271, AATB, ISO 13485, State Requirements and Standard Operating Procedures.

• Inspect and approve human tissue, materials, reagents, and supplies.
• Create, maintain, and inspect to Material and Tissue Specification Sheets.
• Ensure all received and approved human tissue, materials, reagents, and supplies are from approved suppliers.
• Ensure all tissue remains in quarantine until released appropriately and is stored in a manner that keeps tissue separated and segregated and in approved order for easy identification and pulling for processing, labeling, etc.
• Receive and review all required in-process testing results.
• Perform Environmental Monitoring/Personnel Monitoring. Review and document results. Log information into appropriate database.
• Perform Temperature Monitoring. Review and document results. Log information into appropriate database.
• Perform pre- and post-sterilization Tissue Product Inspections and compare against the Product Specification Sheets to ensure compliance.
• Perform inspections at each step of the final labeling and packaging process and ensure documentation is complete and accurate.
• Obtain Tissue Retain Sample(s) for each final lot from distribution team and place in the appropriate area in the Tissue Retain Sample Storage Area. Ensure documentation is complete and accurate.
• Complete all documentation prior to submitting to QA.
• Perform all inspections needed to ensure tissue is properly distributed.
• Ensure work orders and other information needed for billing/payments from QC are completed in real time and accurately.
• Log donors into all applicable databases. All databases/logs MUST be current at all times.
• Prepare trends and graphs.
• Maintaining and provide quality control related metrics to management.
• Assist in creating/revising policies, procedures, specifications and forms for the Quality Control department.
• Any other duties or responsibilities necessary or as assigned.

qualifications:

• BS degree in a scientific discipline (Chemistry, Biology, Physics, Bio-Medical Engineering/Chemical Engineering, etc.) or equivalent education/experience with at least 1 year of Quality Control or a High School diploma with at least 4 years of experience in Quality Control.
• Previous quality control inspection experience in an FDA regulated field, preferred.
• Knowledge of AATB Standards and 21 CFR 1271 regulations, preferred.
• AATB CTBS Certification, preferred.
• Experienced and proficient with Microsoft Office Suite.
• Organized, attention to detail and maintain appropriate analytical skills.
• Experience in applying statistical methods for quality improvements.
• Organized file management.
• Strong communication skills, both written and verbal.
• Professional team player
• Able to lift 40 lbs.

skills: Quality control, SOP, MS-WORD, CAPA, MS-EXCEL, MS-Powerpoint, GMP (Good Manufacturing Practice)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate\'s education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad\'s client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.

Randstad