Junior Engineer; Validation

Contract Pharmacal Corp - Hauppauge, NY

Full-time - Mid Level

Hauppauge, NY

251-500 employees

Chemical Manufacturing

About the position

The position at Contract Pharmacal Corp involves overseeing the quality assurance processes within the pharmaceutical manufacturing environment. The role is crucial for ensuring compliance with regulatory standards and maintaining the integrity of product quality throughout the production cycle.

Responsibilities

• Develop and implement quality assurance policies and procedures.
• Conduct regular audits of manufacturing processes to ensure compliance with FDA regulations.
• Review and approve batch records and quality control documentation.
• Lead investigations into product quality issues and implement corrective actions.
• Train staff on quality assurance protocols and best practices.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, or a related field.
• Minimum of 5 years of experience in quality assurance within the pharmaceutical industry.
• Strong knowledge of FDA regulations and GMP standards.
• Excellent analytical and problem-solving skills.

Nice-to-haves

• Certification in Quality Assurance (e.g., ASQ Certified Quality Auditor).
• Experience with electronic quality management systems (EQMS).
• Familiarity with Lean Six Sigma methodologies.

Benefits

• Health insurance
• 401k plan with company matching
• Paid time off and holidays
• Tuition reimbursement