The Quality Control Associate contractor will be an integral part of a team that performs raw material and finished goods testing. The individual will be responsible for review, generation and sign-off of quality documentation. The ideal candidate will be responsible for interfacing with highly complex systems and controls in an ISO 13485 and cGMP manufacturing environment.
The individual will maintain areas in high state of inspection preparedness by maintaining equipment, records and laboratory environment in order to comply with regulatory requirements utilizing current regulations and Operating Procedures (OP). Additionally, maintains production documents and investigates laboratory exception events and works independently with general guidance from senior team members.
Responsibilities:
Qualifications:
The individual will maintain areas in high state of inspection preparedness by maintaining equipment, records and laboratory environment in order to comply with regulatory requirements utilizing current regulations and Operating Procedures (OP). Additionally, maintains production documents and investigates laboratory exception events and works independently with general guidance from senior team members.
Responsibilities:
- Perform inspection and testing of raw materials, in-process materials and finished goods in a compliant manner
- Document test results, complete batch records, document observations and generate reports for qualification testing
- Conduct data analysis of raw material, in-process and finished goods test results
- Responsible for generating compliant QC documentation as part of the Device History Record required for releasing items into inventory from the raw material to the in-process finished goods
- Maintain records and QC lab environment to comply with cGMP, OP and regulatory requirements
- Support 6S effort and continuous improvement to streamline overall operations and improve efficiency
- Assist in performing maintenance of laboratory equipment
- Assist in regular laboratory and manufacturing environmental monitoring testing
- Assist in reagent and lab supply ordering and inventory management in order to support the QC laboratory
- Ensures equipment is in compliance with calibration standards
- Foster and follow an established safety culture, environmental guidelines and procedures for all work performed
- Assist with troubleshooting of failures in Manufacturing Exception Events by working with others
Qualifications:
- H.S. Diploma Required. Associate's or Bachelor's Degree Preferred.
- 7 years Related experience with a High School Diploma OR 3 years Related experience with an Associate’s Degree OR Less than 1 year Entry level with Bachelor's Degree.
- Strong data-analysis skills, with clear demonstrated understanding of analytical, troubleshooting and problem solving skills.
- Hands on experience in a laboratory.
- Accurate and precise manual pipetting and measuring techniques.
- Ability to utilize electronic office suite of computer programs.
- Experience working in GLP, cGMP or ISO regulated environment preferred.