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Laboratory Data System and Process Auditor

Company: Akorn 2
Location: Franklin
Posted on: May 5, 2021

Job Description:

Provides technical DI SME support and system Data Integrity reviews for data systems used by of Akron Incorporated, across assigned areas such as laboratories (Quality Control(Chemistry and Microbiology), R&D or Quality Analytical Services Laboratories), manufacturing (Process control equipment, including primary and secondary packaging), or general support areas (such as Quality systems, validation systems, distribution or other enterprise GXP systems), as applicable by assigned area and location.

This position is responsible for providing DI Assessment for new implementation, system upgrades/changes or decommissioning, in the assigned area. The individual is directly responsible for system data security review activities and system reviews of computerized systems. This individual is directly responsible for performing routine data system reviews, to review the overall system use, administration and maintenance. The individual is responsible to identify and escalate any concerns related to the integrity of data or system performance, which may be identified during such reviews.

Laboratory Data Systems may include but are not limited to HPLC/GC Systems such as Chromeleon and Empower 3, UV-Vis systems sych as UV WinLab and VisionLite, Software supporting instrumentation such as kinematic viscometers, Autotitrators, HIAC Partical counters, Vitek and Endotoxin testing, iStability Stability management suite as well as any LIMS programs, or controlled Excel spreadsheets in use by laboratory function.

Manufacturing Data Systems may include but are not limited to Steriline processing software, lyophilization controllers, various autoclave software, dispensing/weighing systems, filling automation equipment, online checkweighers, serialization systems such as linemaser and Optel OSM, and controlled Excel spreadsheets in use by Manufacturing

General Support Data Systems may include ERP systems such as JDE Oracle, Veeva or Trackwise Deviation Management, Veeva EDMS, ComplianceWire LMS, Validation systems such as Kaye, Ellab, Vaisala data loggers and controlled excel spreadhseets used to support general quality activities.

This DI SME specialist 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 may need to aid in the development and execution of associated validation activities.


  • Maintain timely documented system reviews of data systems within assigned area
  • Participate in the authorship, execution and approval of GAMP5 computer system validation activities , including input and review to URS, assurance of system compliance internal policies and regulatory guidance for Data Integrity, participation in PQ execution and review of risk assessment based on data process flow with system owners.
  • Provide input in the development, of risk based computerized data migration and verification protocols, and review such protocols to assure alignment to internal and regulatory DI standards.
  • Work cross-functionally to provide input to periodic validation assessments of data systems to assure integrity of data generated within the systems.
  • Participate as a DI SME during system assessment, URS Development, process/system workflow assessment and risk/control assessment, review design, and validation.
  • Provides input to standard operating procedures when required including the review and administration of associated data systems.
  • Actively participate in implementation of new equipment and 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.
  • Serves as a backup administrator to IT Application Support Specialists or Other assigned administrators for software their assigned areas

    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.
    • Well versed in cGMP of the pharmaceutical industry.
    • Must have strong knowledge of software utilized in assigned areas.
    • Excellent computer and software skills.
    • Excellent problem solving aptitude, communication and multi-tasking skills.
    • Must be able to prioritize work assignments independently to meet deadlines established by Data Integrity Management to facilitate continued compliance and business operational priorities. EDUCATION AND EXPERIENCE:
      • B.S. / B.A. in Chemistry or life sciences or other related discipline is preferred
      • Demonstrated proficiency with data systems in area of assignment. Experience in general data system implementation is preferred.
      • 3 years of demonstrated excellence in chemical and/or pharmaceutical quality (cGMP) or closely related IT service function supporting business unit with emphasis on GXP Quality systems is preferred.
      • Demonstrated proficiency in data analysis and pattern recognition utilizing tools such as MSExcel, 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.
      • A combination of education and experience may be considered equivalent to specific educational or experience preferencesJOB PREREQUISITES
        • All full-time employees are required to work a 40 hour week. At times, additional hours during the weekdays, evenings and/or weekends will be required to complete tasks and meet deadlines. All applicants must be able to meet the attendance standards.
        • 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. PHYSICAL DEMANDS/ MENTAL DEMANDS 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. Additional physical requirements include the ability to hear accurately the spoken word with moderate office noise (or plant noise).
          • While performing the duties of the job the employee is frequently required to sit. The employee is occasionally required to stand, walk, and reach with hands and arms as well as being able to lift up to 50 pounds.
          • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Mental requirements include:
            • Ability to write, read and apply technical scientific writing, procedures and quality policies
            • Ability to work independently in an efficient and detail-oriented manner.
            • Ability to work on multiple projects and priorities in a concurrent manner.
            • Ability to work in an independent manner, as well as a group environment
              • Ability to apply deductive reasoning and analytical thought to understand complicated issues.
              • Ability to receive instructions and follow work rules and company policies.
              • Ability to follow safety and security practices.
              • Ability to meet deadlines and effectively deal with a high level of office stress.
              • Ability to maintain confidentiality of certain information

                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.

Keywords: Akorn 2, Paterson , Laboratory Data System and Process Auditor, Accounting, Auditing , Franklin, New Jersey

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