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PDS Tech Inc QC Technician in Bedford, Massachusetts

PDS Tech is seeking candidates for a QC Technician position in Bedford, MA

The Intermediate QC Technician performs Quality Control functions independently or under moderate instruction including: analytical testing, inspection and release of raw materials; inspection of finished packaged goods; issuing of line clearances in support of manufacturing processes; data entry in SAP; water sampling and buffer preparation. The successful candidate will follow and adhere to in-house testing procedures and maintain 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, the Intermediate 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 Continuous Improvement Projects

Required to work on tasks of moderate scope 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 and able to multitask in a fast-paced environment and prioritize work as necessary.

Experience with routine lab techniques such as RI, FTIR, UV/Vis analyses desired

Knowledge of Lean Manufacturing is a plus.

Experience with SAP is a plus

Experience with Trackwise is a plus

*Minimum Qualifications (must have)

High School diploma, with 1-3 years of experience biotech, clinical or equivalent QC laboratory environment.

Must be able to work safely with chemicals, biologics and hazardous materials.

Minimum Requirements:

Requires a BS or higher in Chemistry, Biology, Biotech or related fields, with 1-3 years of experience in a Biotech/Pharma/Clinical QC environment.

Compliance knowledge with ISO9001, ISO13485, ICH Q2, GMP/GLP requirements preferred.

Knowledge of Process Excellence, Six Sigma and Lean Manufacturing is a plus.

Must be able to work independently as well as work with a diverse team. Knowledge of SAP or similar inventory control systems desired. Familiar with Microsoft Excel and Word. Excellent oral and written communication skills are required to be effective in this role.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.