Overview

Position Summary:

The QC Technologist II is responsible for the execution of a broad range of bench test procedures used in raw material qualification, the testing of finished goods prior to release, the investigations of product performance, and for conducting routine validation studies, as well as assisting with routine maintenance of the Quality Control (QC) laboratory. The QC Technologist II assists with resolving product performance issues and maintains the documentation files of approved QC Standard Operating Procedures (SOP) in compliance with applicable regulations and ISO Standards.

The pay range for this position is currently $24-$29/hr. Individual compensation is based on the candidate’s qualifications for the position, including experience, skills, knowledge, education, certifications, internal equity, budget, and/or other business and organizational needs.

Responsibilities

Key Accountabilities

Essential Functions:

• Perform testing of biological raw materials and finished goods per relevant SOP.
• Perform testing for product validation and process validation on existing products.
• Perform testing and prepare reports as required for environmental monitoring or investigation of out-of-specification results, as required.
• Perform testing and assist with preparation of reports for various special projects as deemed necessary by technical review team.
• Responsible for tracking relevant trends.
• Maintain proper laboratory housekeeping and supply levels in the QC laboratory, including submission of purchase requisitions and inventory adjustments.
• Document all test results and maintain product release records (including electronic records).
• Document existing product/process validation test results (including electronic records).
• Maintain product testing database and perform relevant statistical analyses associated with product specifications as specified in laboratory SOPs.
• As required, assist with investigation and resolution of complaints, non-conforming material and product performance issues.
• Submit basic change orders to update procedures as required.
• Ensure and maintain compliance with the Company’s quality system requirements through training and adherence to policies, procedures and processes.
• Other duties as assigned.

Internal Networking/Key Relationships:

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

Qualifications

Minimum Knowledge & Experience Required for the Position:

• High school diploma required; Bachelor’s degree in Science or equivalent experience preferred.
• Thorough understanding of Good Laboratory Practices (GLP) required.
• Work Experince:
  • Without Related degree: A minimum of two (2) years previous Quality Control lab (QC) and/or Quality Assurance (QA) experience required
  • With related degree, a minimum of one (1) years previous Quality Control lab (QC) and/or Quality Assurance (QA) experience required
  • Experience within a regulated medical device manufacturing or In-Vitro Diagnostic Device ( IVDD) strongly preferred.
• Phlebotomy certification ba plus.

Skills & Capabilities

Required Skills:

• Strong 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) preferred.
• Must occasionally lift up to 25 lbs.

Competencies:

• Attention to Detail: 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: Intermediate ability to Juggle Priorities, and support changing busi- ness needs. Exhibit ability to manage a minimum of one project/responsibility with little supervision.
• Collaboration: 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 intermediate issues and problems. These may require some research but still has a higher level employee driving the inves- tigation and resolution.

Travel Requirements:

• No