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Quality Control Analyst
2 months ago
Company Overview
Spectrum Chemical Mfg. Corp, established in 1971, is a prominent player in the fine chemical manufacturing sector, recognized for its commitment to delivering high-quality chemicals, laboratory supplies, and equipment to clients worldwide.
Our facilities are compliant with the US Food and Drug Administration regulations, adhere to current Good Manufacturing Practices, and hold ISO 9001:2015 certification.
Role Overview
The Quality Assurance Specialist will oversee daily operations related to Quality Systems, including supplier qualification, deviation management, change management, and document control.
This role is essential in ensuring that Spectrum maintains compliance with current Good Manufacturing Practices and ISO 9001:2015 Quality standards.
Key Responsibilities
- Collaborate with cross-functional teams to ensure timely completion of deviation investigations, CAPAs, change controls, and DCRs.
- Manage the supplier qualification program, which includes:
- Evaluating supplier self-audit questionnaires.
- Assisting the audit team during quality system audits.
- Tracking supplier performance metrics.
- Establishing Quality Agreements and Clauses.
- Resolving supply chain issues.
- Monitoring CofA challenges.
- Participate in internal, external, third-party, and regulatory audits, providing necessary responses.
- Support project teams and investigations, contributing to process improvement initiatives.
Qualifications
- A minimum of three years of experience in quality assurance or validation within an FDA-regulated environment.
- Proven knowledge of quality systems and regulatory compliance in the FDA-regulated industry.
- Familiarity with global regulatory requirements for validation, including ICH, USP, 21CFR210, 21CFR211, 21CFR11, and GAMP.
- Strong understanding of cGMP and GLP principles.
- Ability to identify issues, conduct thorough investigations, and implement corrective actions.
- Skilled in collaborating with internal and external stakeholders to enhance compliance and operational efficiency.
- Quick learner with the ability to communicate requirements effectively.
- Highly organized with exceptional attention to detail.
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Project).
- Excellent written and verbal communication skills.
- Bachelor's degree (BA/BS) is required.
Work Schedule
*Shifts may vary based on inspection and audit schedules, with potential for additional hours as needed.
- Monday – Friday: 8:00 am – 5:00 pm
- Monday – Friday: 7:00 am – 4:00 pm
- Monday – Friday: 9:00 am – 6:00 pm
