QC Chemist III, Team Lead (Sun to Wed, 6:30 AM to 5PM)
PCI Pharma Services | |
United States, New Hampshire, Bedford | |
23 Commerce Drive (Show on map) | |
Sep 10, 2024 | |
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. JOB SUMMARY This position will have responsibility to support a wide variety and complex activities in the Quality Control Laboratory. This includes testing the following sample types R&D, in-process, finished product, stability, as well as raw materials. Job duties may also include performance of instrument validations, cleaning validations, and method qualifications as deemed appropriate by management. Train others in complex analytical techniques. JOB DUTIES *Perform routine analytical testing of samples supporting incoming raw materials, in-process production, finished product release, long term stability and validation samples. *Ability to independently troubleshoot and solve assay and instrumentation issues *Author and/or review deviation investigation, out-of-specification or aberrant results and process changes *Act as lead in projects within the QC group and the analytical laboratory *Author and/or review of GMP documentation including test methods, protocols, reports and raw data *Independently perform analytical equipment validation, and ensure routine calibration and preventive maintenance is performed at the required intervals *Logging and tracking of samples and chemicals; order chemicals and laboratory supplies as needed *Documents/peer reviews laboratory work using laboratory notebooks/worksheets. Documentation must be detailed, timely and in compliance with cGMP/GDP requirement *Work independently with minimal supervision and direction *May participate in communication between PCI, clients, and analytical testing vendors to support activities including release testing, analytical methods transfer, qualification, validation and implementation *Other duties as assignedPROFESSIONAL SKILLS
EDUCATION
QUALITIES
PHYSICAL REQUIREMENTS & MENTAL DEMANDS
COMMUNICATIONS & CONTACTS Works closely with quality assurance and quality control staff in performing varied work procedures and activities. Interacts with Operations staff. #LI-LL1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: |