The Senior QA/QC Technician performs quality control functions independently or under moderate instruction. Responsibilities include: assays on finished products and in-process test samples; enter data; review data to ensure the final release of finished products and/or components in applicable systems; raw material inspection & release Follow and adhere to in-house testing procedures and in compliance with ISO9001, ISO13485, safety and regulatory requirements as they apply to the laboratory and work areas. Minor local travel by car is required.
In addition, Senior Technician functions as key member of the QC group and may support the following tasks:
Create deviations and OOS report, support root cause analysis and CAPA as requested.
Assist in writing and reviewing new and existing SOPs
Participate in and support training efforts and other department projects.
Participate in and support Continuous Improvement projects
Assay transfer/validation support work
Required to work on tasks where analysis of situations or data requires problem solving skills. Excellent written and oral communication skills are required. Must be self-motivating, detail oriented and comfortable working in a team-oriented environment. Must be able to multitask in a fast-paced environment and prioritize work as necessary.
Familiarity with SAP and Trackwise systems is required.
Working knowledge of AKTA/Unicorn HPLC system desired.
Variety of HPLC experience (SEC, Ion Exchange, Reverse Phase – platforms Agilent Chemstation and PE) desired.
Knowledge of Lean Manufacturing is a plus.
Minimum of A.A.S degree in Chemistry, Biology or Biochemistry or related fields, with 5+ years of experience in biotech, clinical or equivalent QC laboratory environment.
Must be able to work safely with chemicals, biologics and hazardous materials.
Must be able to work overtime
Bachelor degree in Chemistry, Biology, Biochemistry; or equivalent with 3-5 years of experience
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.