Remote Quality Control Specialist (US Markets)

Placements24; Randburg; Ibrido; ZAR 900.000 - 1.200.000; Tempo pieno

Vantaggi offerti da questo lavoro

Flexible remote work

Competitive salary

Health, dental, vision insurance

Retirement savings plan

Professional development

Paid holidays and leave

Company equipment

Descrizione del lavoro

Placements24 seeks a Remote Quality Control Specialist to support manufacturing operations with a focus on US regulatory compliance. The role emphasizes remote audits, review of QC and batch records, CAPA initiation, and collaboration with international teams.

A deep understanding of ISO 9001, GMP and FDA requirements is essential. Applicants should have a bachelor’s degree in a scientific/technical field and at least five years in QA/QC or regulatory affairs, with strong analytical and

Competenze

• Bachelor’s degree in a scientific or technical field such as Chemistry, Biology, Engineering or QA.
• At least 5 years in Quality Assurance, Quality Control or Regulatory Affairs in manufacturing/pharma.
• Strong knowledge of ISO 9001, GMP and US FDA regulations; remote audit experience.

Mansioni

• Conduct remote quality audits of manufacturing processes and documentation.
• Review and approve QC records, batch records and related documentation.
• Identify non-conformances and drive CAPA initiatives.
• Collaborate with global teams to resolve quality issues.
• Develop and update QC procedures and work instructions.
• Analyze quality data to identify trends and risks.
• Provide training on quality standards to internal and external partners.
• Stay current with US market quality regulations and best practices.
• Assist in supplier and third-party manufacturer qualification and assessments.
• Prepare quality reports for management and stakeholders.

Conoscenze

Quality Assurance

Regulatory Affairs

Remote audits

Analytical thinking

Communication

Formazione

Bachelor's degree in a scientific/technical field

Strumenti

Quality Management Software

Descrizione del lavoro

About the Role

Our client, a globally recognized leader in specialized manufacturing and production, is seeking a highly skilled and motivated Remote Quality Control Specialist to support their operations, with a particular focus on ensuring compliance with standards for the US markets. This is a fully remote position, allowing you to contribute your expertise from the comfort of your own home office. The specialist will be instrumental in reviewing quality documentation, performing remote audits, and collaborating with international teams to uphold stringent quality benchmarks. This is an exceptional opportunity to leverage your quality assurance skills in a flexible, remote-first environment, working for a company committed to excellence. The role requires a deep understanding of international quality regulations.

Key Responsibilities

• Conduct remote quality audits of manufacturing processes and documentation to ensure adherence to US regulatory standards and internal quality policies.
• Review and approve quality control records, batch records, and other relevant documentation.
• Identify quality discrepancies and non-conformances, initiating and tracking corrective and preventive actions (CAPAs).
• Collaborate with global manufacturing sites, R&D, and regulatory affairs teams to resolve quality issues.
• Develop and maintain quality control procedures and work instructions, ensuring they are up-to-date and accessible.
• Analyze quality data to identify trends, risks, and opportunities for improvement.
• Provide training and guidance to internal teams and external partners on quality standards and requirements.
• Stay current with evolving quality regulations and industry best practices, particularly those relevant to the US market.
• Participate in the qualification and assessment of suppliers and third-party manufacturers.
• Prepare and present quality reports to management and relevant stakeholders.

Requirements

• Bachelor's degree in a scientific, technical, or related field (e.g., Chemistry, Biology, Engineering, Quality Assurance).
• Minimum of 5 years of experience in Quality Assurance, Quality Control, or Regulatory Affairs within the manufacturing or pharmaceutical industry.
• In-depth knowledge of quality management systems (e.g., ISO 9001, GMP) and experience with US FDA regulations.
• Proven ability to conduct effective remote audits and review complex technical documentation.
• Excellent analytical, problem-solving, and critical thinking skills.
• Strong written and verbal communication skills, with the ability to articulate complex quality issues clearly.
• Proficiency in using quality management software, databases, and standard office applications.
• Self-motivated and able to work independently with minimal supervision in a remote setting.
• Must have a reliable internet connection and a dedicated home office space.
• While the role is remote, occasional travel to manufacturing sites may be required (infrequent).

Benefits

• Highly competitive salary commensurate with extensive experience and remote work.
• Flexible remote work arrangement, offering excellent work-life balance.
• Comprehensive health, dental, and vision insurance coverage.
• Contribution to a retirement savings plan.
• Opportunities for professional development and continuous learning in quality management.
• Work with a diverse, international team and contribute to global quality standards.
• Generous annual leave and paid holidays.
• Company-provided equipment (laptop, etc.).
• Access to online training platforms and conferences.
• Be part of an innovative and forward-thinking company operating from Gauteng .