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Quality Assurance Analyst

2 months ago

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


Oversee and execute the daily operations of Quality Systems, which encompass supplier assessment, deviation oversight, change management, and documentation control.


Support Spectrum Chemical Mfg. Corp. in maintaining compliance with current Good Manufacturing Practices and relevant regulations, as well as adhering to ISO 9001:2015 Quality standards.

Key Responsibilities:

  • Collaborate with multiple departments to ensure thorough completion of deviation investigations, Corrective and Preventive Actions (CAPAs), and change controls.
  • Supplier Qualification Program Management:
    Conduct evaluations of supplier self-audit questionnaires, perform site quality audits, monitor supplier performance, establish Quality Agreements, resolve supply chain issues, and oversee Certificate of Analysis (CofA) challenges.
  • Assist in Customer Quality System Audits, Internal Audits, and Regulatory Inspections as necessary.
  • Manage Customer Change Control Program and provide timely notifications to impacted stakeholders.
  • Support quality investigations as required.
Supervisory Role:
This position does not entail supervisory responsibilities.

Qualifications:
To excel in this role, candidates must demonstrate proficiency in the following areas:
  • Comprehensive understanding of Quality System requirements including ISO 9001:2015, Good Manufacturing Practices (21 CFR 210 & 211), 21 CFR 11, IPEC, and ICH Q7/A.
  • Basic computer skills, including familiarity with software such as Word, Excel, Pagemaker, and Filemaker.
  • A Bachelor's degree (BA/BS) from an accredited institution.
  • Preferred training in Quality System Auditing.
  • Experience in Lean process improvement, Six Sigma, and 5S methodologies is advantageous.
Language Proficiency:
Candidates must possess strong verbal and written communication skills, with the ability to manage multiple tasks effectively. Proficiency in reading, analyzing, and interpreting scientific and technical literature, as well as legal documents, is essential. The ability to respond to inquiries from customers, regulatory bodies, and business associates is required, along with the capability to present information to senior management and public groups.

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

Reasoning Skills:
Ability to apply common sense to follow instructions in various formats and address problems involving multiple variables in standardized scenarios.

Certificates, Licenses, Registrations:
No specific certifications are required for this position.

Physical Requirements:
The physical demands outlined here represent the requirements necessary for successful job performance. Reasonable accommodations may be made for individuals with disabilities.


While performing job duties, employees are regularly required to stand, walk, use hands for handling or feeling, reach with hands and arms, and communicate verbally.

The employee frequently sits and occasionally climbs, balances, stoops, kneels, crouches, crawls, and engages in tasting or smelling tasks.

Employees may occasionally lift and/or move up to 10 pounds.


Specific vision abilities required include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.


Work Environment:
The work environment characteristics described here are representative of those encountered while performing essential job functions. Reasonable accommodations may be made for individuals with disabilities.


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