Safetec of America, Inc. ยท 1 month ago
QC Laboratory Manager
Buffalo, NY
Full-time
Onsite
Senior Level
$85K/yr - $100K/yr
6+ years expSafetec of America, Inc. is a local, family-owned OTC pharmaceutical manufacturing company known for its infection control and compliance products. They are seeking a QC Laboratory Manager to oversee the Chemistry Lab and ensure compliance with regulations while leading a team and supporting quality control initiatives.
ManufacturingMedicalPersonal Health
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
Qualification
Required
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
Company
Safetec of America, Inc.
A Customer-Driven USA Made Brand for Nearly 30 Years. As a U.S.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Scott Weinstein
Chief Executive Officer
Company data provided by crunchbase