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Quality Control Manager

Clinical Resolution Laboratory, Inc
Brea, CA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Skills/Knowledge/Abilities:

  • 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
  • Education/Certification/Experience:
  • 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.
Company Description
Cosmetic and over-the-counter drug manufacturer

Clinical Resolution Laboratory, Inc

Why 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.

Address

1530 Moonstone

Brea, CA
USA

Industry

Manufacturing

View all jobs at Clinical Resolution Laboratory, Inc