Quality Assurance Manager, Arcadia
The Quality Assurance Manager (QA Manager) is responsible for design and implementation of policies and procedures, product specifications and supplier conformance to those specifications to ensure that quality standards are met during production. They establish and maintain protocols to ensure compliance to the cGMP aspects of the entire manufacturing operation including handling, storage, and manufacturing of all activities involved in the production of pharmaceutical grade medical marijuana products. They should understand and be capable of administering a Master Batch Record (MBR) program for all technical operations including extraction, formulation, filling, and packaging processes.
The QA Manager is responsible for the overall quality management system to include corrective and preventive action procedure and system to include analyzing information, identifying and investigating product and quality problems or defects and take appropriate and effective corrective actions. They are also responsible for providing feedback on these processes to internal partners and other team members as appropriate. The QA Manager is the liaison for communication with any regulatory department. The QA Manager is responsible for hiring, training and coaching quality assurance staff (depending on size of operation).
Major Areas of Responsibility include:
- Proper design, monitoring, and controlling of manufacturing processes and facilities, and packaging of products.
- Responsible for the overall quality management system to include Corrective and Preventive Action (CAPA) procedure and system to include collecting and analyzing information, identifying and investigating product and quality problems or defects, and taking appropriate and effective corrective actions. Communicate corrective and preventive action activities to responsible people.
- Champion Change-Control process including requests and deviation database.
- Establish specifications and range deviations and rationales for identity, strength, purity, composition, microbiology and other specification for finished products.
- Establish material traceability, and suspect material quarantine procedures.
- Create and maintain materials such as internal and external Quality Agreements or SOPs and train staff on how to implement and follow them.
- Determine if failure investigation procedures are followed. Verify that appropriate statistical methods are employed to detect recurring quality problems with comparative analyses across different data sources to identify and develop the extent of issues. Verify that there is control for preventing distribution of nonconforming product.
Minimum Qualifications (Skills, Knowledge & Abilities):
- S. Analytical Chemistry, Organic Chemistry, Chemical Engineering, Biology, Industrial Engineering or other related science. 7+ years working in a pharmaceutical or other regulated industry doing liquid/capsule filling, performing audits, writing and creating procedures, and handling quality assurance management.
- Skilled in administering a Master Batch Record (MBR) program for all technical operations to include extraction, formulation, filling, and packaging.
- Skilled in current Good Manufacturing Practices (cGMPs) to include the application of Code of Federal Regulations.
- Skilled in testing of extraction and formulation batches to assure purity and purported potency of commercial products.
- Skilled in Cleaning Validation (CV) program methods and the handling of all aspects of the CAPA process to include deviations and corrective action.
- Skilled in communicating to management and performing corrective action.
- Knowledgeable in the maintenance of all documents, notebooks and records related to instrumentation, calibration and validations and communication with regulatory agencies and laboratories.
- Knowledgeable in High-Performance Liquid Chromatography (HPLC) or similar wet-chemistry testing method for testing and analyzing components.
- Knowledgeable in Microsoft Suite enough to maintain documents, prepare spreadsheets, perform analytics including charts and graphs, and craft presentation material.
- Ability to multi-task, problem-solve and respond with a sense of urgency in a fast-paced environment. Make effective and timely decisions with confidence.
- Ability to communicate effectively, both oral and written, and build and maintain collaborative working relationships with internal and external stakeholders.
Apply directly: https://col-care.com/jobs/#op-343201-quality-assurance-manager