- 179086 - Quality Engineer
- 1 year
- Chipton Ross is seeking a Quality Engineer in Allentown, PA.
o Apply Good Manufacturing Principles in all areas of responsibility.
o Demonstrate and promotes the company vision.
o Review impact analysis of changes to facilities and equipment.
o Review and Approve equipment and facilities qualification documents to ensure compliance with all applicable internal and regulatory standards.
o Informs management of issues identified during qualification activities and recommends appropriate actions to address the issue(s).
o Drives continuous improvement to the site's equipment and facilities qualification/validation program.
o Assist in the review of site procedures related to equipment and facilities as required
o Monitor the site's calibration program.
o Monitor the site's preventative maintenance program.
o Facilitate, participate, and approve Risk Assessment.
o Conduct all activities in a safe and efficient manner.
o Other duties may be assigned to meet business/compliance needs.
o A minimum of 5 years in the pharmaceutical/related regulated industry.
o Experience with equipment and facilities validation Quality Systems.
o Must be detail oriented to detect errors or deficiencies with equipment and facilities qualification documentation.
o Possess the ability to use sound judgment in discerning if equipment and facilities qualification documentation accurately and completely reflects the documentation and requirements of the system.
o Utmost integrity and personal responsibility are required to maintain the highest ethical standards for regulatory compliance.
o Good written and verbal communication skills.
o Thorough understanding of regulatory documentation requirements.
o Knowledge or prior experience with Current Good Manufacturing Practices (cGMP) for pharmaceutical products.
o Ability to work independently.
o Familiarity with or experience in Microsoft Word, Excel, Power Point, TrackWise, and Calibration/PM Systems.
o Mastery of skills required to read, understand, and adhere to the SOPs and policies of a GMP environment.
o Experience in Risk Assessment.
o Bachelor's Degree.
Schedule: Full time
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x307 or (800) 927-9318 x307
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.