Job Title: Quality Assurance Manager
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?Job Description
The Quality Assurance Manager leads all site-level quality and food safety operations at a Massachusetts manufacturing facility that produces annatto-derived ingredients through distillation. This role serves as the site authority on quality systems and regulatory compliance, oversees the implementation and maintenance of the Food Safety Plan, and ensures adherence to applicable FDA regulations (21 CFR 111 and 117). The Quality Assurance Manager manages the site Quality Management System (QMS) and holds quality responsibilities for both warehouse and production activities, acting as the primary quality leader for the entire facility.
Responsibilities
Lead all site-level quality assurance and food safety operations for a manufacturing facility producing annatto-derived ingredients through distillation.
Serve as the site authority on quality systems and regulatory compliance, ensuring alignment with internal policies and external regulatory requirements.
Oversee the implementation, maintenance, and continuous improvement of the Food Safety Plan in compliance with FDA regulations, including 21 CFR 111 and 21 CFR 117.
Manage and maintain the site Quality Management System (QMS), ensuring effective document control, standard operating procedures (SOPs), and quality records.
Ensure compliance with Good Manufacturing Practices (GMP) and applicable regulatory standards across production and warehouse operations.
Oversee quality responsibilities for warehouse and production activities, including inspection, in-process checks, and final product quality verification.
Direct and review batch records and production records to support accurate product release and traceability.
Lead and coordinate internal and external quality audits, including preparation, execution, response, and follow-up on corrective and preventive actions (CAPA).
Implement, monitor, and improve CAPA processes to address nonconformances and drive sustainable quality improvements.
Oversee laboratory-related quality activities, including testing, data review, and verification of food quality and safety parameters.
Ensure effective food safety and HACCP-related practices are implemented, monitored, and documented throughout manufacturing and warehousing operations.
Collaborate closely with production and warehouse teams to support compliant and efficient food manufacturing processes.
Monitor and verify compliance with regulatory requirements, customer specifications, and internal quality standards for all products.
Perform and oversee quality checks, inspections, and data entry related to quality metrics, ensuring accuracy and completeness of records.
Provide leadership, training, and guidance to staff on quality, food safety, GMP, and regulatory expectations.
Communicate clearly and effectively with cross-functional teams to resolve quality issues and support continuous improvement initiatives.
Use analytical, problem-solving, and decision-making skills to investigate quality deviations and implement effective solutions.
Utilize Microsoft Office and project management tools to manage documentation, reporting, and quality-related projects.
Act as the primary quality leader for the facility, overseeing the entire site's quality and food safety performance.
Essential Skills
Bachelor's degree in Food Science, Chemistry, Biology, or a related technical field.
Advanced degree in a relevant technical discipline preferred.
Minimum 5-10 years of progressive quality assurance experience in food, dietary supplements, or ingredient manufacturing.
Deep working knowledge of FDA regulation 21 CFR 117 and familiarity with 21 CFR 111.
Proven experience with quality assurance in a manufacturing environment, including product release and production records review.
PCQI (Preventive Controls Qualified Individual) certification with demonstrated experience in overseeing food safety and product release.
Strong understanding of quality assurance, quality control, and quality management principles in food or ingredient manufacturing.
Hands-on experience with food safety programs, including HACCP and GMP implementation.
Experience with SOP development and management, CAPA processes, audits, batch record review, and document control.
Knowledge of laboratory practices related to food science, chemistry, and biology as they pertain to quality and food safety.
Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, and Access.
Excellent analytical, problem-solving, and decision-making skills applied in a quality and regulatory @context.
Strong communication skills, both written and verbal, with the ability to document clearly and present information effectively.
Demonstrated leadership skills with the ability to guide, influence, and support cross-functional teams.
Experience in food manufacturing, food quality, and food safety compliance within a regulated environment.
Familiarity with regulatory compliance requirements for food, dietary supplements, or ingredient manufacturing.
Additional Skills & Qualifications
Experience in the food and beverage industry, particularly in food manufacturing or ingredient production, is strongly preferred.
Experience in annatto-derived ingredients, distillation processes, or similar ingredient manufacturing environments is beneficial.
Experience with quality checks, inspections, and data entry in a production or laboratory setting.
Exposure to regulatory compliance activities, including FDA inspections or third-party audits.
Experience with project management tools to support quality and continuous improvement projects.
Ability to manage multiple priorities and deadlines in a fast-paced manufacturing environment.
Strong organizational skills with attention to detail in documentation and record-keeping.
Comfort working closely with production, warehouse, and laboratory teams to support operational excellence.
Commitment to continuous improvement in quality systems, food safety, and regulatory compliance.
Work Environment
This is an on-site role based at a Massachusetts manufacturing facility that produces annatto-derived ingredients through distillation. The standard schedule is Monday through Friday from 8:30 a.m. to 4:30 p.m. The work environment includes close collaboration with production, warehouse, and laboratory areas, where adherence to Good Manufacturing Practices and food safety protocols is essential. The role involves working with quality systems, documentation, and regulatory records, as well as spending time on the production floor and in storage areas to oversee inspections, quality checks, and compliance activities. Appropriate professional and safety attire, including any required personal protective equipment, is expected in production and laboratory areas to maintain a safe and compliant facility.
Job Type & Location
This is a Permanent position based out of Hadley, MA.
Pay and Benefits
The pay range for this position is $110000.00 - $140000.00/yr.
PTO, Holiday, Summer Hours
Workplace Type
This is a fully onsite position in Hadley,MA.
Application Deadline
This position is anticipated to close on Jul 22, 2026.
About Actalent
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The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.