Quality Control Manager
- Expired: over a month ago. Applications are no longer accepted.
- Specialize in carrying out and implementing systems and procedures that ensure product quality within an organization
- Ability to interact positively and collaborate with co-workers and management
- Ability to mentor team members
- Managing schedules to abide by the production timeline, monitoring activities, coordinating with production and quality control personnel, assessing employee performance
- Identify Safe Working Environment Protocols
- Plan and coordinate all analytical R&D and QC activities and be able to schedule QC activities with team.
- Create method development and method validation activities for QC products and equipments.
- Review stability study design, monitoring, reporting and data trend analysis
- Ownership of test record review and COC creation.
- Review product related documentation and ensure documentation is accurate and provides necessary information
- Review internal and external complaints to determine the reason for complaint and if an investigation is necessary
- Plans, manages, and controls programs and procedures that maintain an acceptable level of product quality.
- Support and collaborate with all departments on issues pertaining to quality requirements and associated processes. Build and maintain positive and productive working relationships with all departments.
- Responsible for the overall supervision, training, development, coordination and evaluation of QC department staff including Analytical Chemist.
- Authors and/or executes protocols and reports for method validation, method transfer and USP verification
- Provides support for complex technical investigations and projects
- Working knowledge of analytical instrumentation
- Complete Investigation and Deviations (Capa effectiveness) in Trackwise
- Manage in troubleshooting of analytical test methods
- Complies with all company policies and procedures, including safety rules and regulations
- Carries out responsibilities in accordance with the organization’s policies, procedures, and state, Federal and local laws
- Understanding of the principles of analytical chemistry as it applies to HPLC, GC, FTIR, UV-Vis and other general analytical techniques.
- Computer proficiency with comprehensive knowledge of MS Office products, Learning Management Systems (LMS), ERP systems such as SAP or Oracle and manufacturing/quality systems such as LIMS, Trackwise.
- Ability to effectively document a process, explaining scientific and/or technical ideas in writing (technical writing skills).
- Detail oriented with ability to identify errors and/or inconsistencies while performing tasks.
- Knowledge of New Product Development Process, Verification and Validation
- Requires a Bachelor’s degree, preferably in Chemistry or Microbiology, or equivalent education/experience with a minimum of 10 years relevant progressive experience in a Quality Control / Quality Assurance environment.
- Requires working knowledge of cGMP, DEA and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
Clinical Resolution Laboratory, IncWhy Work Here?
Oppotubities for growth. The compensation depends on your level of experience and skillsets.
Cosmetic and over-the-counter drug manufacturer with steady growth for the past 15 years.
1530 MoonstoneBrea, CA
ManufacturingView all jobs at Clinical Resolution Laboratory, Inc