Quality Assurance Specialist

2 months ago

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

Background

Spectrum Chemical Mfg. Corp, founded in 1971 as a fine chemical manufacturing company, is one of the chemical industry's leading customer-focused global suppliers of high-quality chemicals, laboratory supplies and equipment.

Spectrum Chemical Mfg. Corp facilities are registered with the US Food and Drug Administration as a drug establishment, operate under current Good Manufacturing Practices and are ISO 9001:2015 certified.

Coordinate and/or perform the day-to-day activities of Quality Systems such as supplier qualification, deviation management, change management and document control.


Assist in assuring that Spectrum operatesin accordance with current Good Manufacturing Practices & regulations and in compliance with ISO 9001:2015 Quality standards.


Responsibilities

  • Collaborate with various departments to ensure completion of deviation investigations, CAPAs, change controls and DCRs
  • Maintain supplier qualification program:
  • Evaluating supplier self audit questionnaire
  • Assist audit team during site quality system audits
  • Tracking supplier performance
  • Establishment of Quality Agreements/Clauses
  • Supply chain resolution
  • Maintain and monitor CofA challenge
  • Participate in internal, external, third party and regulatory audits and provide responses as needed
  • Support additional project team activities and/or investigations and participate in process improvement activities and projects.


Skills & Qualifications

  • Three years’ experience with quality assurance/validation in an FDA regulated environment is required.
  • Demonstrated working knowledge of quality systems and regulatory compliance requirements within an FDA regulated industry is required.
  • Demonstrated knowledge of global regulatory requirements for validation including ICH, USP, 21CFR210, 21CFR211, 21CFR11 and GAMP.
  • A good understanding of cGMP and GLP is required.
  • Ability to identify and escalate problems, conduct thorough investigations and follow-through with corrective actions.
  • Ability to work closely with both internal and external personnel to increase the level of compliance and cooperation while creating opportunities to improve operations and implement effective solutions to reduce errors.
  • Ability to quickly learn new information and communicate requirements to the appropriate individuals.
  • Highly organized with a strong attention to detail.
  • Proficient in Microsoft Office (Word, Excel, PowerPoint, Project).
  • Strong written and oral communication skills.
  • Bachelor’s degree (BA/BS)

Schedule

*Varied shifts depending on the schedule of inspections and audits. May require additional hours to support business needs.

  • Monday – Friday: 8:00 am – 5:00 pm
  • Monday – Friday: 7:00 am – 4:00 pm
  • Monday – Friday: 9:00 am – 6:00 pm

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