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QC Chemist I


OUR COMPANY:

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, otics, 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.

Summary:
The quality control chemists perform the 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.

Essentials Functions:
Responsible for the laboratory testing in accordance with company SOP's as well as GMP'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, 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 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:
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:
General Science background such as a BS degree in Chemistry or Biology Two years of industry experience involving analytical or wet chemistry test procedures in a Quality Control environment preferred but not necessary.

ADDITIONAL REQUIREMENTS:
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 works with moderate supervision in a detail-oriented manner.

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