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
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:
PHYSICAL DEMANDS, MENTAL REQUIREMENTS, AND WORK ENVIRONMENT
- 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.
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 noiseAbility to apply deductive reasoning and understand complicated issuesAbility to receive instructions and follow work rules and company policiesAbility to follow safety and security practicesAbility to meet deadlines and effectively deal with office stressAbility to accurately communicate ideas, facts and technical informationMaintain confidentiality of certain informationCompany Overview Who we are?
Aside from being a pharmaceutical industry leader with deep roots in the eye care community, Akorn has proven through the years, to be a company of clear vision. A vision of what it takes to continually develop and evolve in order sustain our mission, which is to improve patients' lives through the quality, availability and affordability of our products. Along with developing and manufacturing branded and generic ophthalmics, Akorn manufactures injectable, oral liquid, optic, topical, inhalant, and animal health products. To learn more please visit our website at www.Akorn.com.Why choose us?
Akorn employees are modern day superheroes! That might sound like an exaggeration; however, when you think of it, superheroes help those in need. That is exactly what we do here at Akorn. If you choose to work with us, you are not choosing to work an ordinary job. You are choosing to make an impact in this world. You are choosing to have a career with purpose. If you are seeking a rewarding opportunity where you can make a difference for others, then put on your cape and join the team!!What do we offer?
- Competitive pay
- Growth and development opportunities
- Tuition Reimbursement
- 3 weeks PTO + Personal Days
- 9 company holidays
- 401K match
- Medical, Dental and Vision Benefit Options
- 100% Paid Maternity Leave
- Fast paced, family-oriented work environment
- Wellness Program
- Inclusive and diverse culture
- Adoption AssistanceFlexible Spending Accounts
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.