Posted on: January 23, 2023
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
- Directs and enforces GMP's, GLP's, and safety policiesSkills
- 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
- Facilitates communication among production divisions and
- Assesses test results and approves recommended changes.
- Reviews quality control and quality assurance documentation
such as checklists, logs, and reports for effectiveness, accuracy,
- 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
- 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
- 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
- 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
- Minimum Bachelor's degree in Chemistry or related industrial,
scientific, or Chemical Engineering; Master's degree highly
- 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
Keywords: ProClinical, Hayward , QA/QC Manager, Executive , Hayward, California
Didn't find what you're looking for? Search again!