The Chemist II perform the testing on raw materials, bulk formulations, finished products, stability samples, and any other samples from plant operations which require chemical analysis.
Include the following.
- Physical and chemical testing of, raw materials, bulk, pre-fill, finished and stability products.
- Maintaining stability sample data sheet.
- Ensure all testing performed is properly documented in laboratory notebooks
- Performing peer review of work and documentation of other analysts work.
- Maintaining the work area in an orderly manner.
- Keeps current with all SOPâ€™s required to perform their job assignments.
- Reports any problems with assays or components to the QC Lab Supervisor.
- Responsible for preparing and standardizing any reagents or standard materials required for analysis.
- Reports any supply needs to the QC Lab Supervisor and lab coordinator.
- Disposes of unused samples and laboratory waste in appropriate containers.
- Performs calibration and verification of lab instruments as applicable.
- Revise SOPs, initiate and write change controls, method verification protocol and reports.
- Performs Analytical Method Verification and Transfer as required.
- Performs equipment troubleshooting and supports laboratory investigations.
- Maintain QC laboratory and equipment in good working order.
- Assign and monitor Lab Technician and Chemist I job assignments as required. Train and mentor Lab Technician and Chemist I as required.
Other duties will be assigned as required. Qualifications QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.EDUCATION AND EXPERIENCE:
- BA or BS in chemistry with five years of experience in a lab performing chemistry related duties.
- Experience with High Pressure Liquid Chromatography, Infra-Red (IR), Gas Chromatograph (GC), Ultra Violet/Visible, Particle Size Analysis, KF Titration and wet chemistry skills is required. Familiarity with HPLC/GC analytical software.
- Familiarity with GLP/GMP guidelines.
- Good Communication and writing skills.
- Familiarity with out-of-specification (OOS) and out â€" of â€"trend (OOT) investigations.
- Write OOS and OOT reports
- Computer literate.
- Experience with USP/EP monographs.
PHYSICAL DEMANDS, MENTAL REQUIREMENTS, AND WORK ENVIRONMENT
- Ability to meet attendance standards. All full-time employees are required to work a 40-hr week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.
- Must be detail oriented.
- Flexibility and adaptability in an ever-changing, fast paced environment is essential
- Must have GMP experience in an FDA related environment, inclusive of 21 CFR Part 11 compliance criteria.
- Must have a team work attitude.
Requires sitting and standing. Requires eye-hand coordination and manual dexterity. Requires normal range of hearing and vision to record, prepare and communicate appropriate reports. Will come in contact with hazardous materials. Employee is expected to work with them in a safe manner and use all safety precautions. Work will involve occasional light to heavy lifting.Mental requirements include:Ability to apply deductive reasoning and understand complicated issues.Ability to receive instructions and follow work rules and company policies.Ability to follow safety and security practices.Ability to meet deadlines and effectively deal with office stress.Ability to accurately communicate ideas, facts and technical information.Maintain confidentiality of company business information.Company Overview
Akorn, Inc. is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmics, injectables, oral liquids, topicals, inhalants, and nasal sprays. Akorn markets its products to retail pharmacies, ophthalmologists, optometrists, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies.EEO Statement
Akorn, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
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