Job Details

Company Overview:

Our client is a leading manufacturer of high-quality generic pharmaceutical products. We are dedicated to ensuring compliance with regulatory standards and delivering safe, effective medications to improve the lives of patients worldwide.

Sponsorship is not available, so this is not suitable to candidates with H1B Visa needs.

Job Description:

The Quality Associate will play a critical role in maintaining and improving our quality management systems. This position ensures compliance with FDA regulations and cGMP standards and supports the production of safe and effective pharmaceutical products.

Key Responsibilities:

Quality Assurance:

• Conduct routine in-process and final product quality checks.
• Review and approve batch records, production documentation, and deviations.
• Assist in the investigation of non-conformances and implementation of corrective and preventive actions (CAPAs).

Regulatory Compliance:

• Ensure adherence to FDA regulations, cGMP, and internal SOPs.
• Support internal and external audits, including preparation, execution, and follow-up activities.
• Participate in FDA and other regulatory inspections.

Documentation and Reporting:

• Maintain accurate records of quality activities and inspections.
• Prepare quality reports and summaries for management.
• Review and update SOPs and work instructions as needed.

Training and Support:

• Train personnel on quality standards, SOPs, and best practices.
• Provide cross-functional support to production and regulatory teams on quality matters.

Qualifications:

Education:

• Bachelor's degree in Pharmacy, Biotechnology, Chemistry, or a related field.

Experience:

• 1-3 years of experience in quality assurance or quality control within the pharmaceutical or biotech industry, preferably with generic products.

Knowledge and Skills:

• Understanding of cGMP, FDA regulations, and quality management systems.
• Proficiency in documentation and record-keeping for audits and inspections.
• Strong analytical skills with attention to detail.
• Effective communication and teamwork skills.

Preferred Qualifications:

• Familiarity with handling regulatory inspections or audits.
• Experience working with quality control testing (e.g., analytical methods, stability studies).
• Certification in quality assurance (e.g., CQIA, CQA) is a plus.