- 182938 - Quality Specialist
- 4 Months
- Chipton-Ross is seeking a Quality Specialist for an opening in Allentown, PA.
Our company seeks a Technical Quality Specialists who will be part of the team that is responsible for the Deviation/Complaint Process and Change Control Process. This requires reviewing and approving all process deviations, distribution deviations, client complaints and assessing and approving all change controls. For Deviations/Complaints this requires strong analytical thinking skills, root cause analysis understanding and the ability to partner with colleagues to determine appropriate corrective and preventative actions. For Change Controls this requires being a facilitator of live Change Control Board and the ability to assess changes and their impact to quality/compliance. Decision making needs to be based on strong quality/ compliance principals and appropriate GMP Regulations.
• Apply Good Manufacturing Principles in all areas of responsibility.
• Demonstrate and promotes the company vision.
• Review and approve Deviation Investigations, Complaint Investigations, CAPA and CAPA Effectiveness Checks to ensure all information contained within is accurate per applicable reference documents and also complies with all SOPs and customer requirements.
• Coordinate necessary clarifications or corrections with responsible Investigations and CAPA owners to ensure timely and accurate completion.
• Review and approve Change Controls, Action Items and Change Control Effectiveness Checks to ensure all information contained within is accurate per applicable reference documents and also complies with all SOPs and customer requirements.
• Coordinate necessary clarifications or corrections with responsible Change Control owners to ensure timely and accurate completion of change controls.
• Identify and drive continuous improvement to the site’s Deviation Management, Change Control and CAPAs processes.
• Conduct all activities in a safe and efficient manner.
• Other duties may be assigned to meet business/compliance needs.
• A minimum of 5 years in the pharmaceutical/related regulated industry
• Experience with Investigation Management Quality Systems (e.g. deviation complaints).
• Experience with Change Control and CAPAs.
• Must be detail oriented to detect errors or deficiencies with investigations.
• Possess the ability to use sound judgment in discerning if documentation accurately and completely reflects the documentation and requirements of the investigation.
• 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 Root Cause Analysis.
• Thorough understanding of regulatory documentation requirements.
• Knowledge or prior experience with Current Good Manufacturing Practices (cGMP) for pharmaceutical products.
• Ability to work independently.
• Familiar with or experience in Microsoft Word, Excel, Power Point, and TrackWise.
• Mastery of skills required to read, understand, and adhere to the SOPs and policies of a GMP environment.
System Administrator for Omnify PLM System which includes system setup/maintenance; validation; user account setup/maintenance and users training.
Accredited Bachelor’s Degree
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.