Job description
Assistant Quality Manager
Essential Duties and Responsibilities:
- Oversee Internal Audit process planning and scheduling and serve as the Audit Team Lead in support of other audit team members. Assist in training for, conducting and documenting internal audits and creating reports per procedure to ensure continued compliance to quality management system standards.
- Oversee the equipment calibration program and schedule/implement required annual calibration services with outside calibration providers.
- Manage new product development and product changes using the Change Control process.
- Support new and sustained product/process development and equipment related validation (IQ, OQ, PQ) for production operations as required.
- Work with Purchasing to oversee Supplier Quality to include obtaining supplier audit questionnaire records, maintaining an approved supplier list based on supplier qualification, monitoring Supplier nonconformities, managing the issuance and completion of Supplier Corrective Action Requests (SCAR), and performing supplier audits as necessary.
- Develop sampling plans for incoming inspection of raw materials and packaging components based on supplier technical data and quality performance claims
- Input raw material and finished product test requirements into ERP system.
- Obtain/Maintain supplier Certificate of Compliance, Food-Grade Letter of Guarantee, Child-Resistant Certification, and Component Technical Data records
- Manage the entry and completion of internal corrective actions in Epicor.
- Apply quality principles/methods to investigate root cause, develop/approve corrective and preventive actions for customer complaints, returns, and internal nonconformities, and evaluate overall effectiveness of actions taken
- Support risk and safety initiatives and assist all departments with Job Safety Assessments for PPE.
- Provide quality input/support for development and document control of standard operating procedures, work instructions, forms, and records required for compliance.
- Develop, document, and train quality assurance specialists on inspection requirements and pass/fail criteria for laboratory manufactured products.
- Provide training and support on key quality management practices and assessment tools to include training on procedures, work instructions, record completion accuracy and quality specifications.
Qualifications
- Certification as an ASQ Certified Quality Manager, Lead Auditor, Certified Supplier Quality Engineer, or a Bachelor of Science degree in engineering is preferred.
- 2 – 4 years’ work experience as a quality professional in a regulated industry may be considered in the absence of a degree or certification (experience in the medical/adult use cannabis industry, pharmaceutical, medical, aerospace, or automotive industries preferred)
- Associates Degree in Chemistry, Physical Sciences or Tech Field. Relevant job experience may be considered in place of a 2-year degree.
- Must be able to evaluate quality based on product specifications and alert manufacturing when product is non-conforming.
- Familiarization with ISO 9001, 21 CFR 111 and FDA regulations.
- Positive attitude and works well with others in a team environment.
- Effective time management and multitasking skills.
- Must be 21 years of age or older and able to successfully register with the state’s cannabis commission as an agent.
- Must comply with all laws, regulations, and policies associated with the industry.
Essential Skills
- Maintain the integrity of the quality system, product design, and customer product requirements while maintaining a culture of customer focus.
- Enforce a culture of compliance and performance to the quality management system and regulatory requirements.
- Experience with state and federal standards such as Connecticut DCP Palliative Use of Marijuana 21a-408-1 – 21a-408-72, FDA 21 CFR Part 111, FDA Good Manufacturing Practices, FDA Good Documentation Practices, ISO 9001:2015.
Physical and Mental Demands:
While performing the duties of this job, the employee is frequently required to remain in a stationary position, move and/or position oneself, communicate, operate and/or prepare, place, position objects, tools, or controls. The employee must occasionally move packages weighing up to 25 lb. Specific vision abilities required by this job include close observation and the ability to adjust focus. The mental and physical requirements described here are representative of those that must be met by an individual, with or without reasonable accommodation, to successfully perform the essential functions of this position.
Working Environment:
Work is performed in a warehouse environment. The employee is occasionally exposed to moving mechanical parts and risk of electrical shock. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.
EEO Statement:
We are proud to be an equal opportunity employer. We place priority in an environment of inclusion, diversity and social justice and are committed to securing a better, brighter way forward for our employees, our markets and our communities.
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