GMP Auditor

 

GMP Auditor

 

Leiner Health Product

America’s largest store brand manufacturer of vitamins, minerals, supplements (VMS) and diet aids is searching for an exceptional GMP Auditor.This position is located at the Corporate Office in Carson, California.

For the Opportunity of Your Life.... Come Join Our Team !

Leiner Employees Enjoy (Carson Facility)On-Site Fitness CenterProduct Purchase Program (discount rates)

(Employee Store with over 90+ vitamin/health products items)On-Site Car Wash every WednesdayBusiness Casual EnvironmentAdvantage Club (discount cards to recreation and theme parks)

 

We offer the following benefits: Medical, Dental, Vision, Life, 401K, Employee Assistance Program, Educational Assistance, and Paid Holidays.

 


The GMP Systems Specialist will be responsible for managing in the coordination of GMP systems, including Document Change Control, Equipment Software Change Control (ESCR), Deviations, Corrective and Preventive Action (CAPA), Audit Finding Corrective Action and Out of Specification (OOS) systems utilizing technology current to industry standards.
The GMP Systems Specialist will ensure that technical and compliance issues are consistent with cGMP requirements, and will drive the review process to timely completion in order to support product disposition. Strong and proven knowledge of cGMP, ICH and other regulatory requirements as they apply to API and Drug Product manufacturing and validation is required.


Responsibilities:Manage the lifecycle and organization of Quality System recordsCoordinate the closing of Quality System records and follow-up as required. Assist Quality Auditors with information gathering and agreement among Quality Systems. Provide Quality support to site projects, identifying Quality Systems needed to reach targets. Manage Quality System Records according to the current Record Retention Schedule. Assist QADC and Records Management personnel with workload and projects as needed. Writing detailed SOPs to meet cGMP requirements.  Observe different departments’ personnel performing their job functions and prepare SOPs based on their actions.  Review of master and executed Drug Substance, Intermediate Drug Product, Bulk Drug Product, Packaged & Labeled Drug Product and management of all applicable investigations associated with product, materials and Technical Complaints.

  Requirements.BA/BS degree in a life science degree (chemistry, biology) or equivalent5 years experience in GMP production environment or equivalent academic training. Proficiency in Microsoft Office Suite applications, including Word, Excel and Access. Ability to work independently and proactively in a team environment requiring a high degree of accuracy.Excellent organization, interpersonal and communication skills.Strong background in technical writing and proficiency in oral communication skills.Experience with electronic data systems (LIMS) or electronic documentation systems (Documentum, QUMAS, TrackWise) would be a plus.Certified Quality Auditor or similar highly desirable