QC Lab Technician

Job Title

Two of the headcount will work 2-2-3 (12:00 PM -00:30 AM) after a month on M-F (8 AM-4:30 PM) for onboarding and training. The third headcount will work 2-2-3 (06:00 AM -18:30 PM) after a month on M-F (8 AM-4:30 PM) for onboarding and training.

Description:

• Supports testing a wide range of biological, chemical, or physical analyses on pharmaceutical products (biologics and drugs) through all stages of the manufacturing process from incoming raw materials to finished goods.
• Position is applicable to QC Analytical Testing

Primary Duties:

• Conduct critical biological, chemical and physical analyses of in-process and final products to support manufacturing facility production schedules.
• Perform documentation and review of test data following good documentation practices.
• Enter final data in LIMS and other computerized systems.
• Perform advanced biological and chemical assays requiring precise analytical skills and understanding of biology and chemistry principles.
• Complete all testing, including special project / protocol testing in a timely and appropriate manner.
• Maintain data integrity and ensure compliance with company SOPs, product specifications, FDA, GLP, QSR and cGMP regulations.
• Investigate deviations and write exception documents.
• Participate in team functions to address production, increase efficiency, solve problems, generate cost savings and improve quality.
• Conduct other duties as assigned.

Key Skills and Abilities:

• Proficiency in both manual methods and instrumentation analyses. Experience performing and analyzing analytical assays.
• Proficient in wet and instrumental methods of analyses.
• Knowledge of most laboratory equipment including but not limited to GC, HPLC, ICPMS and other analytical instruments
• Basic knowledge of statistical methods and strong technical problem solving skills.
• Ability to conduct multiple tasks concurrently to meet critical timelines.
• Effective communication skills, ability to train others.
• Proficient use of TrackWise, Empower, and MiniTab software a plus.
• Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
• Knowledge of basic chemical and biological safety procedures
• Good computer skills, knowledge of Microsoft Word, Excel and PowerPoint.
• Able to identify when proper practices/ procedures are not performed.
• Follow SOPs and generate results.

General responsibilities include:

• General laboratory housekeeping.
• Cleaning of laboratory glassware and equipment.
• Operation of equipment preparation and cleaning systems in QC (QC glasswashers).
• Maintenance and stocking of departmental consumable inventory.
• Routine verification of operating parameters of temperature controlled units.
• Routine cleaning and maintenance of temperature controlled units.
• Perform non-batch release testing (e.g. raw materials, cleaning).
• Assist in filling and archiving of departmental data, binders, reports, investigations, etc.
• Maintenance and disposal of waste generated throughout the laboratory.
• Retrieves and receives all samples into the QC Laboratories.
• Logs samples into logbooks.
• Receives samples into LIMS, EBM, and/or JDE.
• Enter data into LIMS.
• Initiate and pull Stability Studies / Samples.
• May lift, push, pull and carry up to approximately 25 lbs.
• Will work around chemicals such as alcohol, acids, and buffers that may require respiratory protection.
• May be required to work or be assigned to a different shift to meet business needs. Must be willing to work off shifts hours.
• Must be able to work supplemental hours as necessary to complete work commitments.
• May be required to work in a confined area.
• Primarily inside working conditions.
• Some clean room and cool/hot storage conditions.