Seeking Compliance Manager for Camarillo, CA

We are a generic pharmaceutical company that specializes in meeting unique labeling and sizing needs for our customers. We are also a leader in pharmaceutical packaging, serialization, and distribution.

The Compliance Manager is responsible for ensuring that various procedures and processes are defined and maintained to meet specific requirements for GSMS and its customers. The Compliance Manager will handle the legal matters, customer expectations and coordinate activities in order to meet quality standards.

Salary Range:
$55,000/yr. – $70,000/yr.

Benefits:
• Employer-Paid Medical, Dental, Vision, Life Insurance, and Long Term Disability (1st after 30 day of Employment)
• Variable Bonus Program
• 8 Paid Holidays
• Paid Time Off
Required:
• Has lab experience.
• Conduct cleaning validation and stability studies.
•Has knowledge in CFR’s, DEA regulations, etc.
Responsibilities and Duties:
Adheres to proper cGMPs including good housekeeping, proper protection of product quality and integrity, and personal hygiene.
Reads and understands written instructions and SOPs.
Knows and understands quality-related SOP requirements that determine appropriate process for conducting job performance.
Identifies and implements Reporting C-II Form “222” process.
Submits Report Form 106 (Theft/Loss Report).
Processes Destruction of obsolete/morgue products.
Reviews and approves SOP processes to reflect current procedures & meet FDA and other regulatory compliance requirements.
Processes MBR, final review, scanning, and retention.
Create, organize, and maintain insert/outsert revision control log (currently out of date or non-existent).
Approve inserts.
Creates, organizes, and maintains component product Certificate of Analysis file per product (currently filed in vendor file).
Approves components
Processes IQ/OQ equipment documentation retention/organization.
Processes Fluke & Humidity Report documentation.
Processes Calibration report documentation.
Completes CA Dept. of Health – biennial renewal.
Processes applications for annual renewal Designated Representatives.
Completes FDA Annual Establishment Registration (annually in December).
Ensures and researches requirements for state-level licenses.
Assigns NDC numbers.
Updates existing files; create new files.
Identifies information required for file documentation.
Submits 2657 for new labels.
Submits 2657 cancellation for “old” labels.
Maintains working knowledge of government and industry quality standards and updates.
Identifies all regulations (in addition to 210 & 211) that may apply.
Evaluates assess impact and steps needed to meet regulations.

Please submit resume only if you have FDA Validation and Stability Experience to hr@gsms.us
www.gsms.us