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; entering data; review data to ensure the final release of finished products and/or components in applicable systems; raw material inspection & release. The successful candidate will 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 team 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
In this role, the Senior Technician will be 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. In addition to standard first shift scheduling this position could be slate to second or third shift to support work/life balance for the successful candidate
- 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.
- Previous direct experience in one or more of the following areas:
- HPLC testing: SEC, IE, RP using Agilent, PE, AKTA
- Microplate format enzyme based luminescent or fluorescent testing (ie Lumiskan Ascent)
- Genetic Analysis by capillary electrophoresis
- Must be able to work safely with chemicals, biologics and hazardous materials.
- Must be able to work occasional overtime
- Minor local travel by car is required.
Bachelor degree in Chemistry, Biology, Biochemistry; or equivalent with 3-5 years of experience
Familiarity with SAP and Trackwise systems is desired.
Knowledge of Lean Manufacturing is a plus.
Availability to work second or third shift