Company: Akorn, Inc.
Location: jersey city
Posted on: May 3, 2021
The Investigations Specialists I is responsible for investigating
deviations that occur within the Akorn Somerset site utilizing
investigation tools (5 whys, fishbone, 6 Ms), to determine the true
root cause. Also, ensures that corrective and preventive actions
(CAPA) are identified and implemented to prevent a reoccurrence of
the deviation. Perform a proper impact and risk assessment to
evaluate product impact per FDA regulations. Write the
investigation reports, verify the effectiveness of previously
implemented CAPAs and track and trend deviations.
- Work with the cross function departments to perform a
comprehensive investigation into deviations, out of specifications
(OOS), and out of trends (OOT) per FDA regulations.
- Gather quantitative and qualitative data from various areas of
operation for analysis of data for investigation.
- Conduct root cause analysis to determine the true root cause of
- Perform product impact analysis and risk analysis for each
- Write deviation reports that are comprehensive, clear, concise,
contain sufficient detail, and will withstand regulatory
- Ensure completeness and accuracy of all deviation reports.
- Ensure all investigations are completed in a timely manner to
ensure closure of all deviations within 30 days from the date of
initiation to comply with internal SOPs.
- Recommend quality process improvements to increase efficiencies
and performance of the quality systems, operations, and personnel
to prevent a deviation occurrences.
- Track and trend non-conformances and recommend additional
actions, as required, to prevent
re-occurrence of the deviation.
- Assist during regulatory inspections or other audits as
- Provide training to function areas on quality related
- Other duties may be assigned
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
EDUCATION AND EXPERIENCE:
Bachelors degree and a minimum of 2 years e xperience in a Quality
role relating to deviations, investigations, out of specifications
(OOS), non-lab out of specifications, and corrective and preventive
actions (CAPA). In addition, experience in performing cGMP related
PHYSICAL DEMANDS, MENTAL REQUIREMENTS, AND WORK
- Ability to meet attendance standards. All full-time employees
are required to work a 40-hr week. At times it may be necessary to
work additional hours in order to get the required tasks
accomplished to meet deadlines.
- Must exhibit strong organizational, communication,
interpersonal skills and attention to detail.
- Proficient with computer programs. TrackWise experience
- Three years of previous quality experience in pharmaceuticals
or related field.
Requires prolonged sitting. Requires eye-hand coordination and
manual dexterity, normal range of hearing and vision to record,
prepare and communicate appropriate reports. Specific vision
abilities required by this job include close vision for written
work and PC use. The noise level is usually fairly quiet.
Mental Requirements include:
- Ability to hear accurately the spoken word with moderate office
noise or plant noise
- Ability to apply deductive reasoning and understand complicated
- Ability to receive instructions and follow work rules and
- Ability to follow safety and security practices
- Ability to meet deadlines and effectively deal with office
- Ability to accurately communicate ideas, facts and technical
- 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, Inc., Jersey City , Investigation Specialist, Other , jersey city, New Jersey
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