QC Analytical Lab Technician / Scientist

• Supports testing a wide range of chemical analyses on pharmaceutical products (biologics and drugs) through all stages of the manufacturing process from incoming raw materials to finished goods.

• 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.

• 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 HPLC, ELISA plate methods, LCMS 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 and Empower 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 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 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 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.

LanceSoft