The Laboratory Data Systems Engineer provides technical support for all data systems used by of Akorn Incorporated Quality Control (Chemistry and Microbiology) Laboratories.
This position is responsible for handling all administrative activities associated with laboratory equipment and computerized systems, including but not limited to HPLC, GC, UV-Visible Spectrophotometer, IR Spectrometer, Karl Fischer Autotitrator, Viscometer, HIAC, Vitek etc. The laboratory system administrator is responsible to assure compliance of laboratory computerized systems to Akorn policies and regulatory standards. The laboratory system administrator is responsible for working collaboratively with system end-users and business process owners to review systems, work-flows and assess risks of process/equipment and aid in the development and execution of associated validation activities. The lab administrator is responsible to work with cross functional teams to perform periodic assessments of laboratory systems and associated supplemental actions to maintain compliance of laboratory systems. Prioritizes assignments to fulfill all Company needs. Assists staff with the troubleshooting of analytical methods/instruments. Administrator for all software types utilized by the Quality Control, Microbiology and Analytical technical services laboratories. Enforces all company compliance and safety requirements. Initiates/Conducts/Completes laboratory investigations following written guidelines in a scientific and expeditious fashion.
- Serve as the computer system application specialist for all laboratory data systems
- Participating in the authorship, execution and review of GAMP5 computer system validation of laboratory systems
- Participate in the development, and execution of computerized data migration and verification protocols
- Prioritize periodic validation assessments of laboratory systems to assure integrity of laboratory data generated within the systems.
- Perform routine queries and system audit trail reviews of all computerized systems within
- Responsible for inventory management of laboratory data systems
- Responsible for initiating and executing change control within laboratory data systems.
- Coordination with vendors as appropriate to troubleshoot and resolve application issues within the laboratory data systems.
- Creates/revises standard operating procedures when required including the review and administration of associated lab data systems.
- Actively participate in implementation of new laboratory equipment and laboratory modernization and compliance initiatives.
- Report risks observed during periodic review of systems through system analysis report with risk documentation
- Communicates effectively with all interdepartmental/intradepartmental personnel. Proactively communicates any problems or delays to all necessary individuals.
- Ensures all Events or CAPA (Corrective Action/Preventive Action) items are completed expeditiously and before the completion date.
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.
- Excellent verbal and written communication skills.
- Must have proven interpersonal skills.
- Must have a working knowledge of current Good Manufacturing Practices, United States Pharmacopeia, current Code of Federal Regulations (21 CFR parts 11, 210, 211, 820) and other FDA regulations and guidance’s.
- Must have strong skills / experience with various types of laboratory testing techniques and instrumentation such as UPLC, HPLC, GC, IR, UV, etc.
- Must have strong knowledge of software utilized for chromatographic data systems.
- Excellent computer and software skills.
- Excellent problem solving aptitude, communication and multi-tasking skills.
- Must be able to meet deadlines established by Quality Control management
EDUCATION AND EXPERIENCE:
- B.S. / B.A. in Chemistry or life sciences or other related discipline is preferred.
- Demonstrated proficiency with CDS, Mettler Toledo LabX, Metrohm Tiamo, etc. software brands utilized by the Quality Control laboratory.
- Minimum of 3 years of demonstrated excellence in chemical and/or pharmaceutical quality (cGMP) or closely related IT service function supporting business unit with an emphasis on Analytical Testing.
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.