The quality control chemists perform testing on raw materials, bulk formulations, finished products, stability samples, and any other samples from plant operations that require chemical analysis. The QC chemists report to the QC lab supervisor.
ESSENTIAL FUNCTIONS:
Responsible for the laboratory testing in accordance with company SOP’s as well as cGMP’s and GLP’s
Testing involves Raw materials, In-process, Finished product, and Stability samples for potency and physical characteristics such as pH, Specific gravity, Moisture, etc.
Maintains lab work area in a neat and ordered fashion
Proficient with the operation of instrumentation such as HPLC, UV, GC, KF, AA and FTIR
Works in support of production may require weekend or off-shift work
May require overtime as necessary to complete high priority work assignments
Has minimal customer interaction
Responsible for additional assigned laboratory duties such as maintaining an inventory of consumable supplies
Maintains data within a laboratory notebook in a neat (legible) and organized manner
Records entries in laboratory logbooks as necessary
Generally works in agreeable conditions. May require extended periods of standing or sitting. Requires the ability to wear a respirator or breathing apparatus
Performs work in accordance with general and specific safety precautions
Responsible for the peer review of co-workers notebook to ensure compliance to SOP’s and cGMP’s
Responsible for ensuring safety and integrity of product testing in the department
Works in a fast paced, moderately stressful environment. Adherence to project deadlines is critical
Interacts with other departments such as Production, QA, R&D on a minimal basis
Consolidates all notebook pages and chromatographic scans with the QC section of the batch record and forwards results to documentation
Reports to the QC supervisor for assignments and annual review
Assists with the orientation of new employees
On occasion works with assignments such as method transfer, validation, and accelerated stability testing
Initiates DCR’s to correct or clarify SOP’s
Requires the ability to work with computers as well as proprietary software
May require sampling of active substances and excipients
Responsible for maintaining confidentiality of work assignments
Qualifications
MINIMUM 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.
Requires superior writing skills.
Requires exceptional attention to detail with the ability to focus on current assignments. While Laboratory mistakes are unavoidable they must be kept to a minimum due to their ramifications.
Requires initiative and self-motivation with moderate supervision in a detail-oriented manner.
Requires the ability to work on multiple projects in a concurrent manner.
Must possess the ability to work in an independent manner, as well as a group environment.
Satisfactory completes initial and annual training for cGMP and corporate operating procedures.
EDUCATION AND EXPERIENCE:
BS degree in Chemistry required. Two years of industry experience involving analytical or wet chemistry test procedures in a Quality Control environment is preferred.
PHYSICAL DEMANDS, MENTAL REQUIREMENTS, AND WORK ENVIRONMENT:
While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear. The employee is required to use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision for written work and PC use. The employee is required to work in a cubicle. The noise level is usually fairly quiet.
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.