Quality Control Associate
• 2nd shift Tuesday - Friday 2:30pm – 11pm, and
• Saturday 1st shift 8am - 4:30pm.
Must have current 1-2 yrs. experience in a quality/GMP environment.
Associate degree is required. Bachelor’s degree is preferred.
Will be working in a semi-warehouse environment performing incoming inspections on donated human tissue and sterilized finished goods.
Computer experience is required: office suite a must, SAP preferred.
Must be able to lift/move 50-100lbs regularly throughout the workday.
Responsible for, but not limited to, performing inspections following procedures, specifications and applicable standards and regulations. Provide technical support to cross-functional teams as needed, identifies potential discrepancies and non-conformance and alert management. Perform porcine and human tissue receipt, and inspection, in-process inspections i.e. e-beam) , and perform product discard as per procedures in an electronic data system. Ensure proper equipment functionality and appropriate levels of supplies.
Supports and partners with cross-functional teams to resolve any issues or non-conformance encountered. Assists in documentation updates and related change controls activities as needed. Perform applicable actions for Non-conformance Reports (NCRs), Supplier Issues (SIs), Engineering Change Orders (ECOs), etc.
--Following procedures, work instructions and specifications perform receipt and inspection of human donated and/or porcine tissue to confirm acceptability for use in Production. Input data into computer systems and prepare related documentation. Ensure proper storage, handling and labeling of tissue to reflect status. Perform work in a clean room as needed. Notify Management of any non-conformance and participate in any related investigations. Attend and complete training required for task performance.
--Perform visual inspection of in-process of packaged product as in e-beam to ensure compliance with procedures. Complete and maintain all related documentation in accordance with good documentation practices. Notify Management of any non-conformance and participate in any related investigations. Attend and complete training required for task performance.
--Perform discard activities for expired, nonconforming or disqualified materials. Prepare and file all relevant documentation. Attend and complete training required for task performance. Notify Management of any non-conformance or deviations and participate in any related investigations.
--Perform additional department support activities as directed including cross-training and developmental of additional skills.
--Active member in other cross-functional collaborative efforts and attends huddles, team meetings, and project meetings.
--Maintains 5S and ensures inspection areas remain as a safe and pleasant working environment. Ensure appropriate levels of inspection supplies and proper function of equipment.
--Perform administrative tasks for timekeeping, activity reporting, development and team support as directed by management
Education and Experience:
• Associates degree required. Bachelor’s degree preferred.
• 1-2 years of experience in a GMP environment performing Quality Inspection related duties as listed in Key Duties & Responsibilities or related activities.
• Must be able to lift/move 50-100lbs regularly throughout the workday. The incoming tissue and the shippers the tissue in which the tissue arrive can weigh quite a bit. We have had shippers weigh up to 98lbs. There are currently projects working on way to reduce the need for our inspectors to lift the shippers and/or the tissue, but I wanted to make sure there was a realistic expectation when a potential candidate started in the area.
• Ability to work varied schedule with some potential weekend, early morning or late evening hours, if needed.
• Majority of work performed in a warehouse or manufacturing setting. Must be willing to work with potentially bio-hazardous materials, including cadaver tissue
• Ability to walk, lift, bend, climb, squat, stoop, stretch, stand, and sit for long periods of time.
• Must be willing to work with potentially bio-hazardous materials.
• AATB certification preferred.
Essential Skills, Experience, and Competencies (includes Licenses, Credentials):
• Advanced computer skills – high knowledge and understanding of Windows based computer systems such as Microsoft Office Suite.
• Experience with Current Good Manufacturing Practices (cGMPs) and working in a regulated industry; familiarity with AATB, ISO, FDA, and/or USP regulations guidelines.
• Experience with Enterprise Resource Planning (ERP) software, such as Oracle or SAP.
• Demonstrated knowledge of Quality Control inspection techniques. Basic knowledge of statistical techniques and quality tools
• Strong organizational abilities and problem-solving skills
• Detail-oriented and self-motivated
• Ability to carry out detailed written or oral instructions
• Ability to work and communicate (soft skills) with others in a professional and effective manner to build strong customer relationships.
• Ability to handle a wide variety of tasks under critical time constraints
|Will this position require driving? || || |
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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