Maintains and coordinates investigation action plan to assure that all excursions 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. Assists the Manager in the scheduling and coordination of staff to meet aggressive project timelines.
- Using root cause determination techniques, perform Deviation, Non-Conformance, OOS, OOT, field complaint and event excursion investigations to determine the root cause and effective preventative action implementation to prevent recurrence of the event in trackwise.
- Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates.
- Work with cross-functional teams to develop and track CAPA plans.
- Working with operations personnel in performance of effective investigations.
- Evaluate trends of investigations and CAPAâ€™s to identify major areas of opportunity for improvement.
- Able to trouble shoot quality assurance complain, CAPA, and investigation issues in consultation with subject matter experts and management.
- Previews and reviews completed Maintenance Work Orders as part of the Quality Assurance audit function.
- Supervise team on projects
- Evaluate and incorporate training programs to enhance root cause training and investigation writing
Qualifications MINIMUM QUALIFICATIONS:
- Ability to work effectively as a team and independently.
- Proficient at Microsoft Outlook, Excel, and Word.
- Strong communication skills and presentation skills
- Ability to abide by quality standards.
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. 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.EDUCATION AND/OR EXPERIENCE:
Bachelor of Science in a Quality / Process related field or equivalent experience. 2 years of root cause analysis experience in a manufacturing, packaging, engineering, and distribution environment, preferably pharmaceutical of FDA regulated operation. Prior knowledge of Track Wise system is a plus. PHYSICAL DEMANDS, MENTAL REQUIREMENTS, AND WORK ENVIRONMENT:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations must be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit, stand, walk, use hands to finger, handle or touch, reach above shoulder, talk and hear. Specific vision abilities required by this job include close vision, distance vision, depth perception and ability to adjust to focus. 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 Who we are?
- The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
- Pharmaceutical, sterile cleanroom requiring special gowning.
- Exposure to equipment use and maintenance / calibration for sterilization, depyrogenation, washing, filling, packaging, etc. pharmaceutical products.
- Manual and high speed packaging operations.
- Pick and packaging of pharmaceutical products for commercial distribution.
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 patientsâ€™ 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 Assistance
- Flexible 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.
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