St. Petersburg, USA
- The Analytical Research and Development (AR&D) laboratory supports evaluation and testing of raw materials, excipients, APIs, in-process and finished product samples. AR&D also performs development and validation of methods used to support release and stability testing of non-commercial products and materials. The department provides analytical services to manufacturing, process development, validation and new material qualifications. AR&D interacts with clients to provide not only research and testing of products, but also support CMC development activities in support of client regulatory filings. Activities are performed in accordance with specifications, standard operating procedures, approved test methods and/or protocols, regulatory requirements, and St. Petersburgs Quality departmental policies.
- Independently test Raw Materials by both compendial and non-compendial methods with support of additional activities related to the testing of pre-capsulation, Stability and Finished Products as required. Analyze data, document results, maintain laboratory notebook according to cGMP and Internal guidelines. Communicate results in written and oral presentations. Help in writing Procedures, Specifications and Test Methods. Keep abreast of literature in field; help train colleagues; contribute to continuous improvement within the group. Comply with FDA, EPA and OSHA regulations, 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, fill moisture, raw materials, and cleaning verification and validation samples according to the assigned specifications, methods and protocols.
- Preparation of reagents/standards/medias needed for analysis according to established methods.
- Safe handling of potent and teratogenic compounds. Disposal of hazardous waste according to environmental regulations and company/departmental procedures.
- Tabulation and interpretation of results of analysis as recorded in notebooks, reports and logbooks. Capable of self-scheduling of work assignments. Assures right-first-time execution of departmental methods and SOPs.
- Facilitates and supports activities and services necessary to the routine operations of the department, as assigned. 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 as required. Supports Material Evaluation Process for new materials if required.
- Provides project support for new product development which requires a close working relationship directly with Customers as well as suppliers. Participates in inter-departmental task teams. Interfaces with peers in other departments, senior management, customers and regulatory agencies. Provides support for ordering and maintaining inventory of laboratory materials and equipments. Provides training for new or existing personnel.
- Identifies and implements process improvements that will reduce cycle time to test and release products.
- Performs other miscellaneous duties as required.
- Works flexible hours including weekends and evenings to accommodate the production / validation schedule.
- Individuals primary workstation is located in the lab, where the noise level is low.
- Candidates may be asked to work some weekend hours (with advance notice.).
- Minimum BS in Chemistry, Biology, Microbiology or related sciences.
- 5 years relevant pharmaceutical laboratory/analytical experience.
- Experience with common pharmaceutical laboratory equipment including, but not limited to,
- U.V. spectroscopy
- IR and AA instrumentation
- H.P.L.C. and G.C. 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
- Data acquisition applications and databases, Empower software
- cGMP standards.
- Demonstrated history of method development and/or validation.
- Demonstrated critical thinking ability with experience in conducting and writing laboratory investigations.
- Ability to work effectively under pressure to meet deadlines.
- Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds.
- Vision requirements include ability to differentiate color (Pass the Ishihara Color Vision Screening) and obtain 20/30 acuity in both far and near vision in each eye with or without corrective lenses. For client in-house screening, the acceptable score is to identify at least 4 of 6 numbers in the circles.
- Be accessible to manufacturing, laboratory and office staff.
- Be able to use required office equipment
Zolon Tech, Inc. (ZTI) is a fast-growing, 8(a) certified business providing Information Technology solutions and services to Federal and commercial clients. ZTI is CMMI Level 3, ITIL, and ISO 20000 certified and is a leader in the IT industry. Headquartered in Herndon- VA.
Location: St. Petersburg,
Apply for this job now.