• Perform testing of finished goods per relevant SOP.
• Perform testing for product validation and process validation on new and existing products and demonstrate the ability to understand the validation. Assist with the development of validation, including feedback on testing requirements and turn around time.
• Maintain proper laboratory housekeeping and supply levels in the QC laboratory, including submission of purchase requisitions and inventory adjustments and exhibiting knowledge of product usage based on planned production to ensure safety stock and continued supply.
• Document all test results and maintain product release records (including electronic records).
• Maintain product testing database and trending associated with product specifications as specified in laboratory SOPs.
• As required, coordinate and assist with investigations and resolution of complaints, non-conforming material and product performance issues, including recommending and orga- nizing test protocols for investigation.
• Perform testing of biological raw materials, including range generation or characterization. Organize and complete associated paperwork. As required, manage concentration selec- tion and release. Organize and schedule basic testing requirements with minimal supervi- sion.
• Perform testing and prepare reports as required, such as environmental monitoring reports or investigation of out-of-specification results, as required.
• Responsible for tracking and analyzing trends related to release testing. Ability to use analysis of trends to provide input on product issues and results.
• Perform testing and assist with preparation of reports for various special projects as dee- med necessary by technical review team.
• Responsible as a subject matter expertise in at least one product line.
• Submit complex change orders to update procedures as required.
• As required, interact independently with cross-functional teams to obtain information on testing, provide feedback and information, and demonstrate critical evaluation of testing requests. Assist the cross-functional team to investigate and resolve issues.
• Exhibit ability to manage multiple projects/responsibilities with little supervision.
• Ensure and maintain compliance with the Company’s quality system requirements through training and adherence to policies, procedures and processes.
• Other duties as assigned.

• Quality Release, Research and Development, Quality Engineering, and Manufacturing Persononel.

• High school diploma required, Bachelor’s degree in Science or equivalent experience pre- ferred.
• Work Experience:
  • Without Related degree: A minimum of five (5) years previous Quality Control lab (QC) and/or Quality Assurance (QA) experience required
  • With Related degree: A minimum of four (4) years previous Quality Control lab (QC) and/or Quality Assurance (QA) experience required
  • Previous experience within a regulated medical device manufacturing or In-Vitro Diagnostic Device (IVDD) strongly preferred.
• Thorough understanding of Good Laboratory Practices (GLP) required.
• Practical experience with laboratory controls, internal audits, and lab training/maintenance.
• Phlebotomy certification a plus.
• Knowledge of FDA-GMP/QSR and ISO standards for quality.

• Excellent written and verbal communication skills.
• Ability to work independently and as part of a team.
• Proficiency with common laboratory techniques, such as pipetting and use of balances.
• Proficiency with Microsoft Office suite.
• Proficiency with Large Enterprise Resources Planning (ERP).
• Must occasionally lift up to 25 lbs.

Competencies:

• Attention to Detail: Advanced ability to pay close attention to detail is required
• Accuracy: Work is accurate and completeness of records
• Outstanding Performance Standards: Demonstrated ability to meet department goals
• Communication: Good written and verbal communication skills
• Discretion: Acts Honest, Loyal, trustworthy
• Multi-Tasking: Advanced ability to Juggle Priorities, and support changing busi- ness needs. Exhibit ability to manage multiple projects/responsibilities with little supervi- sion.
• Collaboration: Advanced ability to actively develop a network to bring best solutions to the team or customer
• Independence: self-motivated-works under minimal supervision
• Professionalism: Must demonstrate professionalism during all interactions within com- pany, customer and third parties
• Takes Initiative: Serves as a role model for “Quality First” by continuously improving on what matters most to customers
• Problem Solving: Promptly and effectively handles advanced issues and problems with minimal supervision or management.

• No