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.
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
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.