- Job Level:
$27.00 - $29.00/hr.
Our client is currently in need of a contract Scientist to support the QC laboratory testing functions.
- Perform physical and chemical tests and assays on raw materials, active pharmaceutical ingredients, in-process and finished products, using various wet chemical, physical and instrumental techniques.
- Plan and execute testing to meet established deadlines.
- Ensure that the laboratory testing techniques and documentation comply with GMPs, SOPs
- Record data and results
- Ensure that all information is entered into databases for trending and capacity modeling purposes.
- Review and approve data and results
- Assist in performing investigations of out-of-specification and out-of-trend data and communicate to the manager and affected departments.
- Monitor metrics and communicate information and recommendations to QC Manager.
- Initiate, author and revise test procedures, SOPs, technical reports, and other documents.
- Maintain and improve laboratory efficiency by implementing improvements, new techniques, training, new processes and/or improvements to work flow.
Minimum of a BS Degree in Chemistry or related discipline
Experience & Skills Required
- At least 5 years of pharmaceutical QC Laboratory testing experience in a cGMP-regulated laboratory environment.
- Knowledge of GMP, USP/NF, ICH, DEA, EU and FDA guidelines and regulations.
- Excellent communication skills.
- Expertise in Microsoft Word and Excel.
- Strong troubleshooting and investigation skills.
- Thorough knowledge of laboratory test procedures and instrumentation, especially HPLC; USP/NF methodology; relevant regulatory requirements.
- Ability to read and interpret test procedures, manuals, technical documents or instructions in mathematical or diagram form, SOPs and governmental regulations.
- Ability to summarize and explain such documents to the QC Laboratory staff as well as to non-scientists.