Laboratory Data Systems Specialist
Akorn 2

Vernon Hills, Illinois

Posted in Science and Research


This job has expired.

Job Info


This position is responsible for handling business process administrative activities and system data security review activities associated with laboratory equipment and computerized systems, including but not limited to HPLC, GC, UV-Visible Spectrophotometer, IR Spectrometer, Karl Fischer Auto titrator, 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 specialist is responsible for working collaboratively with system end-users and business process owners to review systems, workflows and assess risks of process/equipment and aid in the development and execution of associated validation activities. This individual is directly responsible for performing routine data system reviews and identifying and escalating any concerns related to the integrity of data or system performance which may be identified during such reviews. This individual is responsible to work with cross functional teams to perform periodic assessments of laboratory systems and recommending supplemental actions to maintain compliance of laboratory systems. Prioritizes assignments to fulfill all Company needs. Assists management by providing reports and system audit summaries for laboratory systems upon request. Serves as a backup administrator to IT Application Support Specialists for software utilized by the Quality Control, Microbiology and Analytical technical services laboratories. Enforces all company compliance and safety requirements. Initiates/and participates in laboratory investigations following written guidelines in a scientific and expeditious fashion.

  • Serve as the computer system application specialist for all laboratory data systems, demonstrating an understanding of the various available system logs and providing support to use such logs in investigative or routine review purposes.
  • Participating in the authorship, execution and review of GAMP5 computer system validation of laboratory systems, including input and review to URS, assurance of CDS compliance to internal policies and regulatory guidance, participation in PQ execution and review of risk assessment based on data process flow with laboratory system owners.
  • Participate in the development, and execution of risk based computerized data migration and verification protocols
  • Provide input to 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 Akorn Laboratories Responsible for aiding in the execution of change control within laboratory data systems, as needed to support compliance and business needs
  • Provides input to 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


Qualifications
  • Minimum of B.S. / B.A. in Chemistry or life sciences or other related discipline is required
  • Demonstrated proficiency with CDS, Mettler Toledo LabX, Metrohm Tiamo, etc. software brands utilized by the Quality Control laboratory is preferred
  • 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 is preferred.
  • Demonstrated proficiency in data analysis and pattern recognition utilizing tools such as MS Excel, Minitab, Tableau or other data visualization/analytics programs is preferred.
  • Knowledge and understanding of database structures and designs, and SQL database is preferred.
  • Experience in process mapping and HACCP evaluation, and FMEA risk assessment is preferred.
  • 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 guidances.


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.


This job has expired.

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