Laboratory Data System and Process Auditor
Company: Akorn 2
Posted on: May 5, 2021
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
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
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
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
- 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
- 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
- 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
- Ensures all Events or CAPA (Corrective Action/Preventive
Action) items are completed expeditiously and before the completion
- Serves as a backup administrator to IT Application Support
Specialists or Other assigned administrators for software their
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
- Excellent computer and software skills.
- Excellent problem solving aptitude, communication and
- 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
- 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
- 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
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
- Ability to work on multiple projects and priorities in a
- Ability to work in an independent manner, as well as a group
- Ability to apply deductive reasoning and analytical thought to
understand complicated issues.
- Ability to receive instructions and follow work rules and
- 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
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.
Keywords: Akorn 2, Paterson , Laboratory Data System and Process Auditor, Accounting, Auditing , Franklin, New Jersey
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