QC Laboratory Manager

Safetec of America•Buffalo, NY

11d

About The Position

Safetec of America, Inc. has been your trusted source for infection control, first aid, and compliance products for over 27 years. We 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!

Requirements

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

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.