QC Chemist III
The QC Chemist III performs the testing on raw materials, bulk formulations, finished products, stability samples, and any other samples from plant operations that require chemical or physical analysis. The QC Chemist III will coordinate and assist in investigative testing, developmental product and method testing within the QC Laboratory. The QC Chemist III will demonstrate technical expertise in QC functions and will provide expert level technical troubleshooting to the QC team. The QC Chemist III will act as a mentor to less experienced analysts in the QC Team. The QC Chemist III will work in a detail-oriented, compliant manner in a fast-paced, moderately stressful environment, on multiple concurrent projects and is expected to adhere to tight deadlines with shifting priorities. The QC Chemist III is expected to perform and review all data for conformance to approved quality standards and must report any nonconformance or deviations to management in a timely manner for immediate investigation. This individual must be able to perform all tasks associated with QC Chemist II with routinely demonstrated excellence. The QC Chemist III reports directly to the QC Manager but may receive guidance or assignments from QC Supervisors.
ESSENTIAL FUNCTIONS
– Daily set-up, operation, troubleshooting and maintenance of instrumentation such as HPLC, UV, GC, KF, AA, FTIR, ICP-MS in accordance with written SOPs
– Provides technical project leadership, participating in protocol development and execution for test method development, validation/verification and related activities
– Provides expert level troubleshooting of laboratory equipment, methods and processes
– Maintains lab work area and documentation in a neat and ordered fashion
– Maintains data within a laboratory notebook in a legible and organized and compliant manner, and transcribes or enters data into necessary records in an accurate and timely manner
– Reviews generated data in a timely manner and elevates any Non-Conformance, Out of Specification, or other Deviation to Laboratory Management in a timely fashion for further investigation.
– Performs investigative testing or other functions to assist with laboratory investigations.
– Assists in execution of training and acts as a mentor to less experienced analysts.
– Works in support of production and development projects and may require weekend or off-shift work or overtime as necessary to complete high priority work assignments
– Interacts regularly with other departments including R&D, RA, QA and Validation to ensure priorities are aligned and projects are on track.
– Reviews procedures and completes required documentation or update as appropriate as part of Periodic review process
– Performs laboratory testing of Raw materials, In-process, Finished product, and Stability samples for potency and physical characteristics in accordance with company SOP's as well as cGMP's
– Manages projects to improve laboratory compliance and efficiency.
– Works on developmental products, and methods and projects to support R&D initiatives
– Works with computers as well as laboratory software, or proprietary software as needed
ADDITIONAL RESPONSIBILITIES
– May require technical review of old data for Regulatory responses.
– Responsible for the appropriate documentation and disposal of unused laboratory samples and expired reagents.
– Maintain and demonstrate a high level of personal and professional integrity and report any suspicious activity to laboratory management.
– Assists Laboratory management on special projects and assignments
– Additional responsibilities may be assigned by Laboratory Supervisors or Managers, as needed
Requirements:
Basic Qualifications
– B.S. or higher in Science Field, Chemistry Degree Preferred.
– 10 or more years of demonstrated excellence in the field of analytical chemistry.
– Prior experience in a pharmaceutical (cGMP) laboratory setting is required.Preferred Qulifications
– Demonstrated technical expertise in instrumental laboratory analysis.
– Prior Project management experience.Position can be hired as a QC Chemist II or Chemist III depending on experience.
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.
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.
