- 174229 - Quality Engineer - PA
- Up to $34.50 DOE
- 11 Months
- Chipton-Ross is seeking a Quality Engineer for an opening in Allentown, PA.
Apply Good manufacturing Principles in all areas of responsibility.
Demonstrate and promotes the company vision.
Maintaining current equipment and facilities qualification documentation.
Perform impact analysis of changes to facilities and equipment.
Review and Approve equipment and facilities qualification documents to ensure compliance with all applicable internal and regulatory standards.
Informs management of issues identified during qualification activities and recommends appropriate actions to address the issue(s).
Drives continuous improvement to the site’s equipment and facilities qualification/validation program.
Assist in the authoring of site procedures related to equipment and facilities as required
Monitor the site’s calibration program.
Monitor the site’s preventative maintenance program.
Author qualification documents as required.
Conduct all activities in a safe and efficient manner.
Other duties may be assigned to meet business/compliance needs.
Minimum of 5 years in the pharmaceutical/related regulated industry.
Experience with equipment and facilities validation Quality Systems.
Experience facilitating FMEAs and risk assessments.
Experience in reviewing temperature, humidity, and differential pressure data from internal computer systems.
Must be detail oriented to detect errors or deficiencies with equipment and facilities qualification documentation.
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.
Utmost integrity and personal responsibility are required to maintain the highest ethical standards for regulatory compliance.
Good written and verbal communication skills.
Thorough understanding of regulatory documentation requirements.
Knowledge or prior experience with Current Good Manufacturing Practices (cGMP) for pharmaceutical products.
Ability to work independently.
Experience in Microsoft Word, Excel, and Power Point.
Experience in Trackwise and Maximo.
Accredited Bachelors Degree
Tyler Harrell at email@example.com
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x342 or (800) 927-9318 x342
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
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.