Sr QC Technician

Work Schedule

Weekend days

Able to lift 40 lbs. without assistance, adherence to all Good Manufacturing Practices (GMP) Safety Standards, cold room/freezers
-22°F/-6°C, fluctuating temps hot/cold, laboratory setting, loud noises (equipment/machinery), office, rapid flashing lights, some degree of PPE required (safety glasses, gowning, gloves, lab coat, ear plugs, etc.), standing for full shift, strong odors (chemical, lubricants, biological products, etc.), various outside weather conditions, will work with hazardous/toxic materials.

The Sr. Technician – QC Sample Management will be performing a variety of duties to support Quality Control – Sample Management. Responsibilities of Sample Management include chain of custody, dispensing to laboratories, preventative maintenance of equipment, managing reference standards and critical reagents, shipping samples to sites as applicable, and aliquoting from bulk material. This person is responsible for drafting procedures, participating in special projects, and performing more elaborate functions as required.

• Documentation of all activities to meet cGMP / cGDP requirements. Maintain compliance in assigned work and follow all safety procedures, to include the use of Person Protective Equipment.
• Perform and complete area assigned equipment preventive maintenance as requested.
• Performs routine Sample Management tasks: sample pick-up, aliquoting, LIMS, kitting, critical reagent management, sample shipment, sample disposal.
• Clearly and accurately communicates status of samples (picked up, for testing, for send-out) to cross-functional area teams.
• Participate in cross-functional activities.
• Maintain up to date training records.
• Participate in 1‑1's, meetings, attend meetings as necessary to facilitate area needs based on changes, etc. (lean activities).
• Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintains the necessary compliance status required by company and facility standards.
• Author Sample Management documents in the site electronic document management system.
• Investigate and complete investigation of minor sample management deviations.

• Minimum two (2) years of college in a Science or Engineering related field (Biology, Biochemistry or Chemistry preferred).

• At least 2 years of related experience in biopharmaceutical or pharmaceutical industry preferred.
• At least 2 years of experience in a cGMP laboratory preferred.

• Working knowledge of GMP regulations in a GMP environment.
• Knowledge of cGMP practices and asep tic techniques.

• Analytical skills.
• MS Office.
• Strong math skills.
• Strong prioritization skills.
• Detail oriented.
• Results driven.
• Safety Mindset.
• Electronic document system.
• Trackwise or equivalent deviation system.
• Electronic Sample Management System (LIMS).
• SAP.
• Electronic Laboratory Monitoring (Lab Watch or BAS).

• Able to read, write, and communicate in English.
• Able to understand and carry out instructions.
• Reliable.
• Strong communication (written and verbal).
• Effectively multi-task.
• Able to work in an environment of change.
• Able to work independently and as part of a team.
• Able to recognize problems developing, not just occurring.
• Occasional heavy lifting or moving required.