Amerilab Technologies is a growing organization that has a strong employee centric environment. If you are looking for an environment where your contributions are appreciated and work life balance is important, come join our team! We have industry leading medical and PTO benefits!
The QC Manager is responsible for maintaining compliant GMP systems and controls for Amerilab’s analytical laboratory. Manages all aspects of the QC laboratory. Provides direction and development opportunities for QC staff. Quality Control is responsible for in-coming material inspections, release, stability, and development testing activities. Responsible for test method development and validation for Amerilab. This role also provides technical support to internal and external customers.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Responsible for scheduling QC personnel and resources to ensure activities are completed to meet organizational commitments.
- Responsible for in-coming inspections and sampling, and all internal and external laboratory testing.
- Responsible for test method development and validation activities for Amerilab.
- Responsible for hiring, developing, and evaluation of Quality Control personnel.
- Ensures receipt, testing and disposition of components are performed in accordance with Good Manufacturing Practices (GMPs) per Code of Federal Regulations Title 21, Part 111, NSF, and other relevant certifying bodies.
- Responsible for ensuring all applicable Standard Operating procedures (SOPs), Test Methods, and protocols are in compliance with GMPs and current industry standards.
- Ensures QC personnel are trained on and follow GMPs, client specifications and SOPs as applicable
- Responsible for all data generated by QC. Ensures data is reviewed to verify it meets requirements defined in test methods, procedures, and specifications.
- Represents QC in project teams, works with client quality for establishing release specifications, development related testing, and test method validation/verification activities.
- Creates, review, and approve procedures and specifications for materials and products.
- Establishes and maintains effective communication and relationships with internal and external clients
- Identifies opportunities for efficiencies for continuous improvement and best practices.
- Support Scientific Service management as directed
- Performs additional duties as needed
- 4 year college degree in Chemistry or related science degree
- 7+ years’ experience in quality control operations in pharmaceutical, food, or nutritional supplement industry
- 5+ years’ experience managing quality control laboratory in pharmaceutical, food, or nutritional supplement industry
- Able to provide clear, accurate direction to quality team to meet objectives and commitments
- Must be organized and able to manage and complete several tasks and projects concurrently
- Must be detail oriented and have with excellent verbal and written communication skills
- Strong critical thinking skills, robust technical understanding of analytical chemistry and instrumentation.
- Well versed with requirements stated in 21 CFR 111, and/or 211 and other regulations
- Experience with method development for UPLC/HPLC and/or ICP-MS.
- Familiar with compendia and testing standards (e.g. USP, FCC, AOAC).
- Experience supporting Regulatory (i.e. FDA) and 3rd Party audits (i.e. client and NSF).