QC / ARD Lab Chemist
The Analytical R&D laboratory supports, development and validation of methods analytical test methods, evaluation and testing of raw materials, and testing of non-commercial materials to support product development. All activities are performed in accordance with specifications, standard operating procedures, approved test methods and/or protocols, regulatory requirements.
Job Type: Full-time
Hours: Monday – Friday, 9 am to 6 pm
- Analyze data, document results, maintain laboratory notebook according to cGMP and internal guidelines. Communicate results in written and oral presentations.
- Contribute to continuous improvement within the group
- Comply with FDA, performing all work in a safe manner. Maintain proper records in accordance with all SOP's and policies.
- Analysis of finished products, in-process materials, raw materials, and cleaning verification and validation samples according to the assigned specifications, methods and protocols
- Preparation of reagents/standards/media needed for analysis according to established methods
- Disposal of hazardous waste by following environmental regulations and company/departmental procedures
- Tabulation and interpretation of results of analysis as recorded in notebooks, reports and logbooks.
- Assures right-first-time execution of departmental methods and SOPs
- Audits and verifies results, including but not limited to, calculations in notebooks/logbooks and results in reports to check for accuracy and integrity of data
- Writes and reviews analytical methods, deviations, protocols, SOPs and any other technical documents
- Provides support for ordering and maintaining inventory of laboratory materials and equipment.
- Performs other miscellaneous duties as required
- Works flexible hours including weekends and evenings to accommodate the production / validation schedule
- Bachelor’s degree from four-year college or university in any of the following disciplines: Chemistry, Biology, Microbiology, or related sciences (as applicable)
- Minimum of 1 year relevant pharmaceutical laboratory/analytical experience
- Experience with common pharmaceutical laboratory equipment including, but not limited to,
- U.V. spectroscopy
- HPLC, and GC instrumentation
- Dissolution testing
- Expertise in wet chemistry techniques such as titrations, extractions, digestions and preparations of test solutions
- Knowledge of the following:
- Safety and hazardous waste requirements
- cGMP cGLP standards
What We Offer:
- Competitive compensation
- Medical, dental, and vision benefits
- Paid vacation, personal time and holidays
- Friendly and professional environment
Send resume to:
Sciecure Pharma Inc.
11 Deer Park Drive, STE 120
Monmouth Junction NJ, 08852