Quality Control jobs in United States

About

We are a distinguished pharmaceutical brand with over sixty years of expertise, now expanding globally with Singapore as our central hub. We are seeking a skilled Senior QC Specialist to be responsible for managing the setup, qualification, and maintenance of QC lab equipment and systems to ensure compliance with regulatory standards. This includes overseeing lifecycle management, supporting method validation, and leading continuous improvement efforts. The role involves coordinating with cross-functional teams, ensuring proper documentation, supporting audits and inspections, and maintaining a safe, compliant laboratory environment.

Responsibilities

1. Manufacturing Plant & QC Lab Setup

• Assist in the setup of the new manufacturing plant and QC lab.

• Ensure the installation of necessary equipment, testing methods, and procedures for smooth operations.

• Coordinate the setup and integration of lab equipment with quality systems.

2. Quality Control Equipment & Compliance Management

• Maintain the site validation master plan and procedures for QC lab equipment.

• Ensure alignment with the site’s Quality & Validation strategy.

• Manage the life cycle of QC lab equipment, addressing obsolescence risks and anticipating capacity needs.

• Oversee the qualification, maintenance, and adherence to scheduled plans for QC equipment.

• Lead compendial compliance assessments and periodic analytical method control trend reviews.

• Recommend improvements based on method performance evaluations.

3. Method Management & Analytical Support

• Support the annual method review in the context of the annual product review.

• Contribute to the invalid assay trending program within the QC lab.

• Establish metrics and monitor qualification activities to identify trends and issues.

• Lead investigations and review method control trends to optimize lab processes.

4. Documentation, Reporting & Quality Control Issue Resolution

• Ensure proper documentation and review of qualification and maintenance deliverables (e.g., risk assessments, protocols, reports).

• Write/review protocols and reports for analytical validation/transfers and qualification activities.

• Record data in compliance with cGMP and data integrity requirements.

• Investigate QC events, issues, or discrepancies and implement remediation actions and CAPAs.

5. Regulatory Compliance & Continuous Improvement

• Support regulatory inspections and audits by providing method validation and equipment management records.

• Lead continuous improvement initiatives for QC lab equipment management and processes.

• Ensure compliance with HSE, quality policies, and site procedures.

• Promote and practice safety in the laboratory while maintaining HSE standards.

• Foster a culture of continuous improvement and regulatory excellence.

6. Computer System Validation (CSV) & Cross-Functional Collaboration

• Lead the development, implementation, and maintenance of lab computer systems, ensuring regulatory compliance (e.g., 21 CFR Part 11, GxP).

• Plan, execute, and document Computer Systems Validation (CSV) protocols (IQ, OQ, PQ).

• Act as a point of contact for CSV and regulatory compliance issues.

• Develop, review, and train staff on SOPs for systems and validation processes.

• Work with IT, equipment vendors, and QA teams for system integration in the lab and production environment.

• Participate in system and technology evaluations to enhance lab compliance and efficiency.

Qualifications and Skills:

• Bachelor degree in Chemistry, Chemical Engineering, Biotechnology, Pharmaceutical Sciences, or related field.

• Minimum of 5 years' experience in quality control within the pharmaceutical industry, with expertise in GMP, regulatory requirements, and lab instruments.

• Expertise in pharmaceutical regulations, global quality policies, data integrity, and analytical methods (wet chemistry and instrumental testing).

• Proficient in QC equipment qualification, method validation, and continuous improvement, with experience supporting GMP inspections.

• Independent decision-making with attention to detail in laboratory activities, testing, reporting, and compliance.

• Strong interpersonal and communication skills to promote a quality-driven culture and advocate for QC during inspections.

What We Offer:

1. Competitive salary and benefits package.

2. Opportunities for professional development and advancement.

3. A dynamic and collaborative work environment.