Billerica, MA US
Perform or assist with all essential tasks including preventative maintenance, calibration, qualification and repair of laboratory instruments in accordance to all applicable SOP to ensure adherence to cGMP in support of the laboratory operation. Assist with instrument maintenance and schedule outside contractor where necessary
- Preparation of master Preventive Maintenance/Calibration schedule.
- Planning, execution and review of instrument calibration/qualification related activities as per the calibration master plan.
- Assist and perform instrument repairs.
- Draft and review of instrument operation, maintenance and calibration procedures.
- Prepare the IQ/PQ/OP protocols.
- Initiate change controls for new and existing instrument and its procedures.
- Concurrent documentation of all the raw data, observations in the notebook or applicable documents.
- Notify to the supervisor any anomalous or OOC results. Notify the management for any observations or deviations.
- Hands on knowledge of lab softwares and functionality .
- Adhere to cGMP and safety procedures.
- Logging and attending instrument repair requests.
- Scheduling visit for outside contractors for preventive maintenance or repair.
- Placing " out of service tag on instrument due for calibration, instrument requiring a repair or on a new instrument.
- Opening the investigations and conduct primary investigation under direct guidance from management.
- Ensure adequate labeling of all instruments and ensure instrument calibration status.
- Order and maintain spare parts for major instrument to ensure continuous support of the analysis.
- Verify the expiry date of chemicals, reagents, primary calibrators prior to use.
Education or Experience
Minimum BS or equivalent degree in Chemistry or related discipline.
Minimum of four (4) years of Pharmaceutical Industry Laboratory experience
Requirements and Qualifications:
In depth knowledge of analytical instrumentation such as HPLC, GC, FTIR, UV and practice.
Practical problem solving skills for instrumentation troubleshooting.
Familiar with lab software's and requirements for their qualification/validation.
Knowledge of ICH and FDA regulatory guidance.
Must be familiar with cGMP/GLP practices for analytical laboratories and EHS/OSHA safety regulations.
Excellent written and verbal communication skills and working knowledge of Microsoft Office Applications.
A self-starter with a hands-on approach and a can-do attitude.
The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).