Operations Compliance Specialist - Micron (1161)

Since 1961 Colorcon has played a vital role in the advancement of film coating technology and solid oral dose development for pharmaceuticals. Our current reputation as the "Supplier of Choice" is based on the superior product quality, unparalleled technical support, and extensive regulatory assistance. Today we are proud to have over 25 locations worldwide, including 18 technical service laboratories, 8 manufacturing facilities and over 1,200 talented individuals - our valued employees. Along with being the "Supplier of Choice" Colorcon is the "Employer of Choice." To learn more about Colorcon and our exceptional culture and benefits package visit our website at http://www.colorcon.com Description



The MTI Operations Compliance Specialist coordinates and ensures Operations compliance with MTI procedures/policies and cGMPs while acting as a liaison between all MTI departments and Operations to ensure timely flow and completion of micronization jobs.

Responsibilities

• Participate in project planning meetings, prepare/review customer instructions
• Prepare batch manufacturing records for processing
• Perform technical review of batch manufacturing records
• Address and reconcile any compliance issues associated with batch manufacturing records
• Assist with coordination of compliance related action items
• Develop, review, and approve relevant Operations policies and procedures
• Review log sheets for compliance to Operations policies and procedures
• Develop, implement and maintain Operations compliance tracking and trending system
• Ensure timely completion of all Operations CAPA items
• Coordinate Operations staff training, as needed
• Monitor Operations training files to ensure records are complete and current
• Initiate, review and approve Quality Reports from a technical standpointRequired Experience



Requirements

• Proficient in MS Word
• Experience in Oracle
• Excellent oral and written communication skills
• Excellent time managements skills
• Ability to be multi-task oriented and highly organized
• 3 or more years experience, with a working knowledge of GMPsIn order to make sure that Colorcon receives all of your information we require that everyone complete our online application at http://www.colorcon.com Please click on this link to be directed to our application: http://hostedjobs.openhire.com/epostings/jobs/submit.cfm?fuseaction=dspjob&jobid=259738&company_id=15621&jobboardid=24Colorcon is an Equal Opportunity Employer (EOE M/F/D/V)