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QA/QC Manager

Company: ProClinical
Location: Hayward
Posted on: January 23, 2023

Job Description:

Proclinical is seeking a QA/QC Manager for an innovative laboratory located in Hayward, CA. This position will develop, implement, and periodically evaluate programs, policies and procedures to ensure the organization's production operations, from raw materials to finished products, meet the quality, integrity, and efficiency standards set by the organization, FDA and other outside agencies regulations.Must be eligible to work or be a citizen in the US.Job Responsibility:

  • Directs and oversees the quality control and quality assurance departments and supervisory staff, including all training to ensure the familiarity by all members of team with correct formats and procedures for labeling as well as external environment and proposed US regulations / guidance.
  • Conducts performance evaluations timely and constructive.
  • Works with Human Resource Department for discipline and termination of employees in accordance with company policy.
  • Directs and oversees all preparations and implementation of new standard operation procedures (SOP's), Test Procedures, and Specifications.
  • Directs and enforces GMP's, GLP's, and safety policiesSkills and Requirements:
    • Evaluates production operations from a strategic level to ensure that products meet quality, integrity, functionality, and other specifications and requirements.
    • Preparation of responses to Regulatory authorities, supplements, and amendments; participation in final company document review and corrections; preparation of additional information as needed.
    • Collaborates with management and senior staff across production departments and roles to draft acceptable quality standards.
    • Develops and implements quality standard testing and evaluation processes.
    • Facilitates communication among production divisions and management.
    • Assesses test results and approves recommended changes.
    • Reviews quality control and quality assurance documentation such as checklists, logs, and reports for effectiveness, accuracy, and relevance.
    • Provides regulatory oversight of changes in manufacturing facilities, processes, procedures, and testing methods.
    • Keeps apprised of new regulations, standards, policies, and guidance issued by regulatory authorities that may impact the company and shares information accordingly to staff and executive management.
    • Conducts random inspections and quality control checks.
    • Periodically reports status of quality and operations to executive leadership and, as required, regulatory agencies.
    • Performs other related duties as assigned.
    • Excellent verbal and written English communication skills with the ability to train staff in all aspects of QA and QC Departments
    • Thorough understanding and experience of FDA, QSR, GMP's and drug cGMP and ability to train staff to meet requirements
    • Thorough knowledge of 21 CFR 820
    • Thorough understanding of quality control and quality assurance standards and methodologies.
    • Thorough understanding of manufacturing and production within the skin care manufacturing industry.
    • Experience in USFDA and ISO auditing and ability to lead team to successful audits
    • Experience with designing and developing test cases based upon system specifications documentation, including overseeing all data integrity
    • Excellent organizational skills and attention to detail.
    • Strong analytical and problem-solving skills.
    • Strong supervisory and leadership skills.
    • Proficient with Microsoft Office Suite or related software.
    • Minimum Bachelor's degree in Chemistry or related industrial, scientific, or Chemical Engineering; Master's degree highly preferred.
    • Minimum 10 years of QA/QC experience in OTC drugs and cosmetic manufacturing or similar industry.
    • Minimum 5 years direct Supervision of QA/QC team members
    • Minimum 5-7 years of experience in leading company to maintain GMP, ISO and FDA Regulations
    • Experience in cleaning validation, process validation and supply chain management.
    • Certified ISO auditor preferred
    • ISO 9001: 1 year (Preferred)If you are having difficulty in applying or if you have any questions, please contact Christina Chung at (+1) or .Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.Proclinical Staffing is an equal opportunity employer.

Keywords: ProClinical, Hayward , QA/QC Manager, Executive , Hayward, California

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