QC Laboratory Manager

Safetec of America Inc. has been your trusted source for infection control first aid and compliance products for over 27 are a local family-owned OTC pharmaceutical manufacturing company with a reputation for retaining employees because we treat them like family.

We are always looking for talented people to join our team. If you have the ambition and drive to take on new challenges as the next step in your career apply today!

Responsibilities:

• Manages all aspects of the Chemistry Lab (Analytical Testing Stability and Outside Testing Services) to ensure compliance with all applicable procedures and regulations.
• Provides QC leadership and support across the organization. Facilitate cross-functional communication and ensure all testing metrics projects and departmental goals are achieved.
• Supports activities for method development qualification validation and verification from assay development.
• Ensures the review/approval of raw materials/components stability studies and finished goods is performed per cGMP/GLPs. Supports the completion of laboratory investigations and ensures implementation of corrective and preventative actions relating to OOS/OOT investigations and QC activities as appropriate.
• Recruits trains and manages team within the department fostering collaboration. Assigns work coaches staff and performs performance reviews and disciplinary actions as necessary.
• Creates new and performs periodic review of approved department procedures specifications methods etc. to ensure compliance with industry standards.
• Oversees consumable inventory and preventive maintenance/calibration activities for laboratory instruments.
• Serves as primary contact for and supports internal external and regulatory inspections.
• Performs other tasks as assigned.

Qualifications Education and Experience:

• BS required Chemistry Microbiology or other related scientific field
• 6-8 years of supervisory experience within a pharmaceutical/regulated laboratory environment supporting manufacturing operations.
• Experience writing non-conformances laboratory investigations and OOS/OOT required; experience with Root Cause Analysis.
• Experience with regulatory inspections from the FDA Health Canada or other agencies.
• Experience performing wet chemistry LC GC FTIR and UV analytical methods
• Strong organizational communication and troubleshooting skills; ability to prioritize and lead through complex processes/projects