To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.  The Quality Operations Manager will be responsible for the following tasks (tasks may include, but are not limited to the following):

1. Creation and review of SOPs and Quality Operational Procedures
2. Perform batch record reviews
3. Conduct in-house cGMP training and awareness programs for Quality Operation Inspectors & Specialist
4. Managing customer complaints
5. Ensure, through subordinates, customer and consumer complaints are recorded, investigated, and trends in complaints are monitored as part of post market surveillance and product vigilance activities
6. Ensures, product safety incidents are escalated for regulatory and senior management review
7. Ensures through subordinates that the CAPA system are effective and that CAPAs are monitored for timely close out
8. Monitor Non-Compliance reports and take corrective actions to assure timely completion
9. Provide support to Director Quality & Regulatory Affairs in Regulatory Affairs & FDA audits to adhere to audits requirements
10. Perform Internal Quality Audits and provide support in handling audits by external auditing agencies
11. Ensure the labels for new drug and/or nutritional product are under the compliance

Education and/or Experience

• The ideal candidate must have a BA/BS in Science or related with at least 6 years pharmaceutical and/ or nutritional or related industry in a quality management role or an advanced degree with +3 years of experience
• Strong Knowledge of GMP, CFR & other Regulatory Compliance
• Experience working in manufacturing and/or environment 
• Should have a commanding knowledge and understanding of quality in the manufacturing environment
• Able to handle multiple tasks/projects simultaneously
• Should have the ability to work at a fast pace, work with interruptions, and deal effectively with confidential information 
• Must have the ability to be flexible and proactive; able to practice good prioritization; maximize efficiency; and have good organizational skills 
• Must be willing to work late or during weekends, if needed
• Must have ability to work with a diverse cultural environment
• Detailed oriented, patient, and thorough
• Must be a TEAM player
• Strong interpersonal skills for routine interactions with managements
• Experienced at providing verbal and written reports to the Director Quality

The Quality Control Laboratory Manager will manage Analytical Laboratory staff with emphasis on testing activities including current Good Laboratory Practices (cGLP) compliance, analytical accuracy and the ability to meet scheduled timelines, while maintaining and updating quality system.

Must posses excellent supervisory and inter personnel skills and be able to communicate with subordinates, peers, and management process and technical solving skills are essential.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.  The Quality Control Lab Manager will be responsible for the following tasks (tasks may include, but are not limited to the following):

1. Maintain highest standards of Quality in our products
2. cGMP training
3. Maintain analytical accuracy
4. Must meet scheduled timelines
5. Ability to design & validation new test methods
6. Approve test results and monitor trends to assure company’s ability to meet current Good Manufacturing Practices (cGMP) and companies standard operating procedures
7. Reviews documentation for thoroughness, clarity and compliance to all internal and external requirements
8. Responsible for conducting and hosting customer and regulatory quality laboratories audits
9. Ensure customer satisfaction and product quality
10. Perform detailed Out of Specification (OOS) investigations to determine reasons for product deviations
11. Lead failure and root cause investigations within Quality Operations department and support production investigations as needed
12. Assists with reviewing and approving laboratory SOPs & Analytical Procedures
13. Keep SOPs & APs (Analytical procedures) updated as well as keeping the lab personnel trained on changes in procedures
14. Evaluate and recommends new instruments purchases for the laboratories
15. Develop qualification studies of new product, stability studies, and lab instrumentations
16. Perform and operate all laboratories test methods and instruments, including HPLC, GC, FTIR, UV/VIS Spectrometer
17. Work closely with the VP of Quality Systems & Regulatory Affairs to ensure proper level of Quality, Productivity, GMPs, and Employee morale are maintained within the department

Educations and/or Experience

• The ideal candidate must have a BA/BS in Chemistry, Science and some related courses in Microbiology and /or at least 5 years pharmaceutical and/ or nutritional or related industry in a quality system or an advance degree with +3 years of related experience
• Knowledge of GMP, CFR & other Regulatory Compliance
• Strong back ground in instrumentation (HPLC/GC) and computer skills with a solid understanding of the principles of Chromatography and ability to trouble shoot analytical instrumentations
• Experience in method development and validation would be helpful
• Experience working in manufacturing and/or environment 
• Have a good knowledge and understanding of quality in the manufacturing environment
• Highly flexible, Able to handle multiple tasks/projects simultaneously
• Should have the ability to work at a fast pace, work with interruptions, and deal effectively with confidential information 
• Must have the ability to be flexible and proactive; able to practice good prioritization; maximize efficiency; and have good organizational skills. 
• Must be willing to work late or during weekends, if needed
• Must have ability to work with a diverse cultural environment
• Detailed oriented, patient and thorough
• Must be a TEAM player
• Strong interpersonal skills for routine interactions with managements
• Experienced at providing verbal and written reports to the Director Quality