Quality Control Associate

Quality Control Specialist

Requirement/Must Have:

• 1+ years work experience, preferably in regulated industry with High School Diploma.
• 3+ years work experience with an Associate’s Degree.
• Less than 1 year work experience, entry level with a Bachelor's Degree.

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.
• Perform routine maintenance of laboratory equipment outlined by operating procedures.
• May assist in coordinating vendor activities for user maintained laboratory equipment.
• Perform regular laboratory and manufacturing environmental monitoring testing.
• Perform lab supply ordering and inventory management in order to support the QC laboratory and adherence to inventory control processes.
• Foster and follow an established safety culture, environmental guidelines and procedures for all work performed.
• Formulate reagents with high complexity for material testing process.
• Act as QC representative in transferring processes from development to QC.
• May assist in testing raw materials for reliability and stability.
• May assist in process monitoring and trending.
• May assist in collecting, interpreting and communicating process metrics for recommended improvements.
• Assist in performing, reviewing and/or generating validations for QC processes and laboratory equipment.
• Assist in the development and implementation of testing processes.
• Assist in reagent manufacturing activities unrelated to QC activities.

Nice to Have:

• Experience with handling corrosive and biohazardous reagents.
• Experience working in GLP, cGMP or ISO regulated environments.
• Experience with 6S and Lean techniques.

Skills:

• Excellent oral and written communication skills demonstrated by communicating with other functions and management regarding resolving testing, investigations and theory.
• 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.
• Demonstrated attention to detail and strong organizational skills.
• Ability to utilize Google suite and computer programs.
• Proven ability to meet deadlines.
• Demonstrated ability to work effectively in a team environment.
• Ability to work in department and/or cross functional meetings and projects.
• Proficient ability to perform a wide range of moderate and high complexity laboratory techniques and their application.

Qualification And Education:

• High School Diploma.
• Associates or Bachelor’s Degree in Science or Life Science discipline.