Analysis of in process, intermediate, raw material, packaging material, ETP and utility samples, stability samples, R&D samples and other samples as per plant requirement as per defined STP’s.
Calibration of all equipment in QC department as per SOP’s.
Maintain the records of calibration, working standards, stability data, AMC, outside calibration records, instrument log book, validation report, in process and intermediates test reports as per GLP.
Perform analytical method validation as and when required.
Perform analytical method development project as and when required.
Lab/Facility Chemist performs chemical analyses of hazardous and non-hazardous waste to determine compliant treatment and disposal.
Compensation
The pay range for this position is $22.85 to $31.40* which reflects the minimum wage in multiple jurisdictions. The actual range will depend on the locality in which you are hired.
Responsibilities
Performs preparation techniques and instrumental analysis of environmental samples
Participates in the generation of SOPs and Work Instructions
Prepares samples for laboratory equipment
Utilizes instrument sequencing and data processing
Validates methods for testing organics and inorganics
Requirements
No degree required but 3 years relevant work experience
Supports the Quality Management System (QMS) and Document Management System (DMS) in a GMP regulated environment, ensuring compliance with SOPs, GMP/GLP standards and client requirements.
Compensation
The hiring range in Colorado for this position is $93,750/year - $108,750/year and is eligible for a 4% annual target bonus.
Responsibilities
Perform independent quality evaluation and release of support documentation, materials, products, equipment, and/or facilities
Ensure testing/manufacturing performed per approved SOPs/methods/protocols and comply with specifications
Participate in internal, client and/or regulatory audits
Support quality events and root cause analysis
Develop, implement, and maintain procedures and policies to comply with FDA, EU, and ICH requirements
Senior Scientist responsible for method validations, transfers, and verifications on APIs and finished products, applying GMP and leading analytical investigations.
Responsibilities
Perform method validations, transfers, and verifications on APIs and finished products
Apply GMP principles in all responsibilities
Conduct analytical investigations using HPLC, GC, UV/Vis, and dissolution techniques
Troubleshoot instrumentation and coordinate with vendors
Train and mentor junior staff in laboratory procedures
Execute analytical techniques in support of method validation for Active Pharmaceutical Ingredient manufacturing.
Compensation
The full-time equivalent pay range for this position is $85,840.00 - $134,125.00/yr plus eligibility for bonus, stock and benefits.
Responsibilities
Design and conduct laboratory scale experiments using analytical instrument platforms such as HPLC/UPLC, HPLC-MS, ICP-MS, IC, GC, GC-MS, UV, Karl Fischer
Author method validation protocols and reports with adherence to ICH guidelines and internal Agilent standard operating procedures (SOPs)
Design and safely conduct laboratory scale experiments using current best practices for API testing
Properly record and summarize experiments in notebooks and reports and construct research summaries to present to internal teams
Maintain process compliance integrity by adhering to SOPs and current good manufacturing practices (cGMP) as appropriate
Requirements
Bachelor's degree (B. S.) or equivalent in chemistry, or related applied science field
Nice to have: Experience with IC, GC, GC-MS, UV, Karl Fischer
Nice to have: Experience working in a cGMP regulated environment
Nice to have: Knowledge of analytical test methods used in the testing of oligonucleotide API or related molecules
Sr. QA Specialist IICambrex · Longmont, US