Investigation Specialist- Pharmaceutical Manufacturing & Microbiology
Akorn 2

SUMMARY:
The Investigations Specialists I is responsible for investigating deviations that occur within the Akorn Somerset site utilizing investigation tools (5 why’s, fishbone, 6 M’s), 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.

ESSENTIAL FUNCTIONS:

• 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 all deviations.
• Perform product impact analysis and risk analysis for each deviation.
• Write deviation reports that are comprehensive, clear, concise, contain sufficient detail, and will withstand regulatory scrutiny.
• 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.

ADDITIONAL RESPONSIBILITIES:

• Assist during regulatory inspections or other audits as required
• Provide training to function areas on quality related issues
• Other duties may be assigned

Qualifications
QUALIFICATIONS:

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.

EDUCATION AND EXPERIENCE:

Bachelor’s degree and a minimum of 2 years’ experience 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 training.

JOB PREREQUISITES:

• 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 preferred.
• Three years of previous quality experience in pharmaceuticals or related field.

PHYSICAL DEMANDS, MENTAL REQUIREMENTS, AND WORK ENVIRONMENT

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 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 office stress

Ability to accurately communicate ideas, facts and technical information

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.

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