Quality Assurance Specialist in Manufacturing
2 months ago
Company Overview:
Nivagen Pharmaceuticals is a leading organization committed to improving lives through the development and provision of affordable generic medications and over-the-counter products for the North American market. With a decade-long dedication to excellence, integrity, and respect for individuals, our professional team works diligently to advance manufacturing, distribution, and quality assurance processes. We aim to enhance medication accessibility and affordability through innovative practices and cutting-edge technology. Our commitment to employee well-being is reflected in competitive compensation, comprehensive benefits, and extensive training opportunities, fostering a culture of growth and support.
Position Summary:
The In Process QA Specialist plays a crucial role in ensuring that pharmaceutical products adhere to quality standards throughout the manufacturing process. This position involves real-time monitoring, sampling, testing, and thorough documentation to promptly identify and resolve any quality concerns, ensuring compliance with Good Manufacturing Practices (GMP) and regulatory standards.
Key Responsibilities:
- Monitor critical control points in the manufacturing process to avert quality deviations.
- Ensure production processes are consistently aligned with specified parameters and quality standards.
- Collect in-process samples at various production stages for testing and verification.
- Coordinate testing of intermediate products for essential quality attributes, ensuring compliance with specifications.
- Oversee environmental monitoring in controlled areas, maintaining sterility and particulate requirements.
- Review batch production records for completeness and accuracy during manufacturing.
- Document deviations or non-conformances detected during production, ensuring timely resolution.
- Support investigations into process deviations, identifying root causes and assessing their impact on product quality.
- Implement corrective and preventive actions (CAPA) to address issues and prevent recurrence.
- Ensure compliance with GMP, FDA, EMA, and other relevant regulatory standards in all in-process activities.
- Assist during audits by providing necessary documentation and explaining in-process controls.
- Identify opportunities for process enhancements that improve product quality and manufacturing efficiency.
- Train production staff on quality standards and proper documentation practices.
- Collaborate with cross-functional teams to resolve quality issues and implement improvements.
- Work with supplier quality management to ensure raw materials meet quality requirements.
- Participate in risk assessments to identify potential quality issues and develop mitigation strategies.
Qualifications:
- A Bachelor's or Master's degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Biotechnology, or related fields is preferred.
- Two to five years of experience in in-process quality assurance or a related role within a pharmaceutical or GMP-regulated environment is required.
Skills and Abilities:
- Strong analytical and problem-solving skills, particularly in root cause analysis and CAPA implementation.
- High attention to detail in identifying quality deviations and documenting processes.
- Proficiency in quality testing equipment and familiarity with statistical process control (SPC) methods.
- Comprehensive understanding of GMP, FDA regulations, and pharmaceutical industry standards.
- Excellent verbal and written communication skills for effective collaboration.
- Ability to work effectively within a cross-functional team environment.
Job Requirements:
- May require shift work, including nights or weekends, based on production needs.
- Adherence to safety protocols and use of personal protective equipment (PPE) is mandatory.
- Significant time spent on the production floor, monitoring processes in a cleanroom environment.
Benefits:
- Competitive salary range.
- Eligibility for yearly bonuses.
- Comprehensive benefits package supporting health and well-being.
- Medical, dental, and vision coverage.
- Paid time off plan.
- 401k savings plan.
Additional Information:
Nivagen is committed to providing equal employment opportunities to all individuals and fostering a diverse and inclusive workforce. We encourage candidates who may not meet 100% of the qualifications to apply.
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