The Quality Control Manager is responsible for design and implementation of policies and procedures, product specifications and supplier conformance to specifications to ensure that quality standards are met during production. Oversees testing of processes and products and quality assurance activities surveillance programs such as CAPAs. 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. Establishes and maintains protocols to ensure compliance to cGMP for handling, storage and manufacturing of all activities involved in the production of pharmaceutical grade medical marijuana products to include administering a Master Batch Record program for extraction, formulation and filling processes. Reporting to the Site Operations Manager, the Quality Control Manager acts as the liaison with regulatory departments of the State.
Major Areas of Responsibility include:
Responsible for the proper design, monitoring, and controlling of manufacturing processes and facilities, and packaging of products.
Establish specifications and range deviations and rationales for identity, strength, purity, composition, microbiology and other specification for finished 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 take appropriate and effective corrective actions.
Manage internal audit and CAPA database for verification and effectiveness.
Establish material traceability, and suspect material quarantine procedures.
Manage Change Control requests and deviation database for effectiveness.
Draft, review and maintain internal and external Quality Agreements.
Provide quality systems assessment of quality and regulatory affairs functions in collaboration with the respective department managers.
Track errors observed to establish patterns with processes or personnel.
Communicate corrective and preventive action activities to responsible people, providing relevant information for management review, and documenting these activities are essential in dealing effectively with product and quality problems, preventing their recurrence, and preventing or minimizing device failures.
Investigate root cause of errors discovered in the process and write deviation/CAPA
Challenge the quality data information system. Verify that the data received by the CAPA system are complete, accurate and timely.
Verify that appropriate statistical methods are employed (where necessary) to detect recurring quality problems. Determine if results of analyses are compared across different data sources to identify and develop the extent of product and quality problems
Determine if failure investigation procedures are followed. Determine if the degree to which a quality problem or nonconforming product is investigated is commensurate with the significance and risk of the nonconformity. Determine if failure investigations are conducted to determine root cause (where possible). Verify that there is control for preventing distribution of nonconforming product
Minimum Qualifications (Skills, Knowledge & Abilities):
Bachelor’s degree in Chemistry, Organic Chemistry, Chemical Engineering or other related science
7 years’ experience working in a pharmaceutical or similar regulated industry performing liquid/capsule filling, quality assurance management is preferred
Experienced in quality systems, current Good Manufacturing Practices and Code of Federal Regulations.
Experienced in Corrective and Preventive Action methods and procedures.
Skilled in administering a Master Batch Record (MBR) program for all technical operations to include extraction, formulation and filling.
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 and reporting to management and perform corrective action when appropriate, deviations and defects when outside the specifications with a sense of urgency in real time.
Knowledgeable in the maintenance of all documents, notebooks and records related to instrumentation, calibration and validations.
Knowledgeable in High-Performance Liquid Chromatography (HPLC) or similar wet-chemistry testing method for testing and analyzing components.
Knowledgeable in change control procedures and processes.
Knowledgeable in tracking, controlling and reporting controlled substance to regulatory agencies.
Knowledgeable and proficient in Microsoft products such as Word, Excel, PowerPoint, Outlook sufficient 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.
Ability to communicate effectively, both oral and written, and build and maintain collaborative working relationships with internal and external stakeholders.
Ability to demonstrate self-directed and self-motivated work style. Make effective and timely decisions with confidence.
Ability to utilize operating system comprehensively in current and future systems.
Ability to initiate continuous process improvement and production improvement on fact-based feasibility studies and report to results to management.
Ability to act as a liaison with the State Department of Health and designated laboratories.
Additional Abilities Required:
The job requires physical activity, including prolonged standing, repetitive bending, climbing, and lifting or moving up to 10 pounds (or more with a coworker). Good visual acuity, hand-eye coordination, manual dexterity, and ability to perform repetitive motions with accuracy is required. The noise level in the work environment is usually moderate.
Note: Nothing in this job description restricts the company’s right to assign or reassign duties and responsibilities to this position at any time. Reasonable accommodations may be made in appropriate circumstances to enable individuals to perform the essential functions of the position.
About Columbia Care:
Columbia Care Inc. (“Columbia Care” or the “Company”) is one of the largest and most experienced multi-state operators in the medical cannabis industry, with licenses in 15 jurisdictions in the US and the EU. With over 1,000,000 successful sales transactions since its inception, Columbia Care is a patient-centered organization setting the standard for compassion, professionalism, quality, caring and innovation, working in collaboration with some of the most renowned and innovative teaching hospitals and medical centers in the world. The Company is committed to providing the type of education and transparency patients deserve and quality of product that clinicians expect. For more information on Columbia Care, please visit www.col-care.com.
As a condition of employment, all Columbia Care employees are required to submit to a background check. Employment decisions, in compliance with state law, are based on an employee’s background report at the time of hire. Employees have a duty to report any changes in their background to the Market Director or Vice President, Operations as soon as the employee is aware of the event.
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