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Quality Control Analyst

2 months ago

Gardena, California, United States Spectrum Chemical Mfg. Corp. Full time
Position Overview


The Quality Assurance Coordinator is responsible for overseeing the daily operations of Quality Systems, including supplier qualification, deviation management, change management, and document control.


This role ensures that Spectrum Chemical Mfg. Corp. adheres to current Good Manufacturing Practices and complies with ISO 9001:2015 Quality standards.

Key Responsibilities:

  • Collaborate with various departments to facilitate the completion of deviation investigations, CAPAs, and change controls.
  • Supplier Qualification Program Management:
    • Evaluate supplier self-audit questionnaires.
    • Conduct site quality system audits.
    • Monitor supplier performance.
    • Establish Quality Agreements and Clauses.
    • Resolve supply chain issues.
    • Maintain and oversee CofA challenges.
  • Assist in Customer Quality System Audits, Internal Audits, and Regulatory Inspections as required.
  • Manage the Customer Change Control Program and provide notification support to impacted parties.
  • Support quality investigations as necessary.
Supervisory Responsibilities:

This position does not include supervisory responsibilities.

Qualifications:

To excel in this role, candidates must demonstrate the ability to fulfill each essential duty satisfactorily. The following qualifications are representative of the knowledge, skills, and abilities required:

  • Familiarity with Quality System requirements of ISO 9001:2015, current Good Manufacturing Practices (21 CFR 210 & 211, 21 CFR 11), IPEC, and ICH Q7/A.
  • Basic computer literacy, including proficiency in Word, Excel, Pagemaker, and Filemaker.
  • A Bachelor's degree (BA/BS) from an accredited four-year college or university.
  • Training in Quality System Auditing is highly desirable.
  • Experience in Lean process improvement, Six Sigma, and 5S methodologies is preferred.
Language Skills:

Strong oral and written communication skills are essential, along with the ability to manage multiple tasks effectively.

Candidates should be able to read, analyze, and interpret scientific and technical journals, as well as legal documents. The ability to respond to inquiries from customers, regulatory agencies, and business community members is crucial.

Effective presentation skills to senior management and public groups are required.

Mathematical Skills:

Ability to perform calculations involving proportions, percentages, area, circumference, and volume, as well as apply basic algebra and geometry concepts.

Reasoning Ability:

Ability to apply common sense to carry out instructions provided in written, oral, or diagram form and to address problems involving multiple concrete variables in standardized situations.

Certificates, Licenses, Registrations:

No specific certifications are required for this position.

Physical Demands:

The physical demands described are representative of those that must be met by an employee to successfully perform the essential functions of this role. Reasonable accommodations may be made for individuals with disabilities.

While performing the duties of this job, the employee is regularly required to stand, walk, use hands to handle or feel, reach with hands and arms, and communicate verbally.

Occasional lifting and/or moving of up to 10 pounds may be required.

Work Environment:

The work environment characteristics described are representative of those an employee may encounter while performing the essential functions of this position. Reasonable accommodations may be made for individuals with disabilities.

While performing the duties of this job, the employee may be exposed to fumes, airborne particles, and toxic or caustic chemicals. The noise level in the work environment is typically quiet.