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Investigation Specialist at Akorn 2 in Amityville, New York

Posted in Other 30+ days ago.





Job Description:

Oversee and assist with laboratory investigations to ensure compliance with FDA. Coordinate, Write, and Review laboratory investigations including but not limited to non-conformance, deviation, out of specification and out of trend results. Works with management to review and analyze investigations to assure that all non-conformances are adequately investigated for determination of root cause and that corrective and preventive actions are identified and implemented to prevent/reduce excursions in processes and procedures.

ESSENTIAL FUNCTIONS
  • Coordinate, Write, and Review laboratory investigations including but not limited to non-conformance, deviations, out of specification and out of trend results.
  • Experience perform laboratory investigations, including hypothesis testing, root cause analysis, trending, risk and impact assessments.
  • Experience with QC analytical techniques, troubleshooting, Method Validations
  • Using root cause techniques, assist the quality control and operations teams in and / or perform Deviation, Non-Laboratory OOS, OOS, OOT, field complaint and event excursion root cause determination and effective preventative action implementation.
  • Develop and track CAPA plans.
  • Review pending investigations for timeliness and work with investigators to ensure progress is made on outstanding investigations
  • Provides feedback to investigators to ensure all investigations are thorough with appropriate root cause analysis
  • Evaluates and incorporates training programs to enhance root cause training and investigation writing for management and supervisory personnel
  • Good communication skills including providing presenting investigations orally and written updates to management



Qualifications
To perform this job successfully, an individual must be detail-oriented and possess the ability to multi-task and work on multiple projects simultaneously. 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.

SAFETY REQUIREMENTS
Safety glasses, close-toed shoes and latex gloves are required in many areas within the facility

EDUCATION AND EXPERIENCE
  • Minimum Bachelor's (BS) or Master's Degree in a chemistry related field
  • Minimum 5 years R&D, QC and / or QA experience in the pharmaceutical industry performing method development, validation, analytical testing, problem solving and troubleshooting techniques
  • Minimum 5 years' experience performing and documenting QC laboratory investigations in the pharmaceutical industry
  • Experience using Empower or other LC Software is a plus
JOB 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 complete 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, PC use and evaluation of test specimens.


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.