Job Description:
- With limited supervision, QC Associate II, is responsible for the performance of direct materials testing in accordance with cGMP regulations.
- These duties include execution of laboratory testing, trend analysis, documentation review, support of discrepancies (OOS, OOT, OOE) and other laboratory support activities.
- In conjunction with Quality Control leadership, the QC Associate II works to meet departmental and organizational goals.
- Perform a broad variety of basic and moderately complex tests with documentation according to GMP.
- Review data and assess against established acceptance criteria.
- Perform technical review of peer-generated data and evaluate data to identify trends and/or establish limits.
- Identify discrepancies; provide input to design of quality investigations and CAPA (corrective actions preventive actions) initiatives as needed.
- Identify and troubleshoot technical problems, identify gaps in systems and procedures, receive and provide training.
- Participate in assay transfer and assay validation and perform equipment qualification / maintenance.
- Prepare and maintain standards, controls, stocks, cultures, etc. per established procedures.
- Support the maintenance and compliance of operational areas.
- Assure and apply GMP throughout operations.
- Recent bachelor’s graduates within the life sciences or engineering. Experience in internship/co-op or MINIMAL post graduate is a plus.
- Pay: $25-28 hourly, depending on experience level
- Onsite, M-F, 8am-5pm
- 6-month contract, potential for extension/conversion