Quality Control Associate

Job Description

The Quality Control Associate - Reagent Manufacturing 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.

Qualifications

• Education Requirements: High School Diploma, Associates or Bachelor’s Degree in Science or Life Science discipline
• Experience: 7 years work experience, preferably in regulated industry with HS Diploma 3 years work experience with an Associate’s Degree. Less than 1 year work experience, entry level with a Bachelor's Degree.
• Knowledge & Abilities: Excellent oral and written communication skills, strong data-analysis skills, proven math skills, hands-on experience in a laboratory, accurate and precise manual pipetting and measuring techniques, demonstrated attention to detail and strong organizational skills, proficiency in Google suite and computer programs, ability to meet deadlines, proven ability to work effectively in a team environment, proficiency in performing a wide range of moderate and high complexity laboratory techniques and their application (titration, spectroscopy, protein analysis, tissue testing, etc).

Quality and Safety, Compliance

• Maintains Right to Operate and ensures that all processes are performed in a safe and healthy manner; addresses and escalates any potentially unsafe hazards; accurately performs tasks in a regulated environment (OSHA, NMPA, FDA, etc.).
• Conducts out of specification (OOS) and supports non-conformance investigations, reworks, and corrective actions.
• Serves as a contact for other departments regarding QC related activities.
• Acts as QC representative in the review of and provides feedback on document changes, including redlines provided by external teams (Development, Operations Scientists, Design Transfer Operations, project teams, etc).
• Maintains complete and accurate records including daily metrics.

Continuous Improvement

• Cultivates and follows an established safety culture, environmental guidelines and procedures for all work performed.
• Conducts 6S activities, gathers/meets cycle times and develops/follows standard work; identifies and implements process improvements and continuous improvement initiatives utilizing lean tools.
• Participates and contributes in team meetings.
• Participates in process improvement projects.
• Participates in the collection of data for daily metrics purposes and to support operational excellence initiatives and improvements.

Teamwork and Collaboration

• Proactively collaborates with peers and with other functions to ensure targets are achieved.
• Assists in onboarding by conducting training of new employees and contractors.
• Provides suggestions to improve work processes and laboratory equipment.
• Engages in cross functional technical activities such as quality investigations and product design transfer.
• Fulfills roles in department and/or cross functional meetings and projects.
• Supports the QC team to ensure smooth operation and adherence to standards and communicates to cross functional teams.