We are seeking an experienced Quality Assurance Manager to ensure that our products and services meet all quality control requirements before they reach customers. You will plan, organize, direct, and monitor the daily activities of QA specialists, and promote a quality culture within the company.

Essential Duties and Responsibilities:

Responsibilities:

Establish quality controls, monitoring, feedback, and improvement practices in all manufacturing and distribution facilities.
Assure all products produced at the facility is cGMP and FDA compliance through supervision of QC Associate.
Support document control and change control tasks.
Monitors and controls raw materials and finished product testing. Implement and follow quality standards and policies. Suggest changes in procedures, documentation, and measuring and testing equipment.
Collaborate in the review and auditing of cGMP documents, execute internal audits, cooperate with corrective action and preventive actions, as well as deviations and investigations.
Design, implement, and manage Food Safety Plans that comply with FSMA standards and customer requirements.
Completes customer questionnaires and documents requests from customers in a timely manner.
Review, monitor and ensure supplier qualification program and material qualification programs are completed within the designated timeframe.
Design and implement risk-based supplier qualification program.
Lead difficult discussions with customers (including laboratories) and employees and find acceptable resolutions.
Liaise with contract laboratories and suppliers to discuss various test methods. Closely monitor contract laboratory testing and adherence to standards.
Understand customer and stakeholder requirements to develop effectual QC processes.
Establish procedures for sampling, recording and reporting data, including approval of QC data.
Support cross functional team with input as needed from a quality perspective for customer specific audit/testing/inspection requirements for manufactured products.
Oversee sampling/testing program for incoming ingredients/packaging, in-process materials, and finished products.
Manage unsellable and non-conforming inventory.
Coordinate GMP and Food Safety Training for all personnel.
Oversee micro and EMP testing process to verify compliance.
Work with sanitation to validate cleaning process and implement corrective actions.
Investigate and respond to customer and consumer complaints.
Conduct out of specification investigations and CAPA’s.
Conduct and participate in quality audits to ensure quality policies adhere to regulatory requirements.
Routinely report on Key Performance Indicators, lead continuous improvement activities.
Handling regulatory affairs

Required Qualifications:

Bachelor’s degree in biology, Science, Quality Management, Engineering, Business Administration, or a related field.
Experience: At least 8+years cGMP experience in a FDA regulated industry; including previous experience as a QA or QC manager.
10+ years providing quality assurance support to cGMP pharmaceutical or nutraceutical production (other regulated industry).
5+ years of leadership experience.
Strong working experience with GMP, FDA, NSF, CFR 211, USDA.
Experience in Quality Management systems
Certified PCQI
Keen eye for detail, excellent communication.
Planning skills, follow-up, and follow-through
Experience and confidence to actively engage team in process enhancements and corrective actions
Collaborates well with all levels while making things happen
Thorough knowledge of methodologies of quality assurance and standards
Results driven approach
Excellent organizational and leadership skills
Excellent communication skills (verbal and written)
Experience with 3rd party Audit systems
Familiar with test methods for microbiology and environmental sampling
Strong computer skills, including MS Office expertise (Excel, PowerPoint, Word, Teams)
Experience with Oracle NetSuite, Microsoft Dynamics 365 a plus
English fluently. Spanish is a plus.

The above statements describe the general nature and level of work only. The statements do not represent an exhaustive list of required responsibilities and skills. Other duties may be added, or this job description may be amended at any time. This job description does not alter an employee’s at-will employment status or create an employment agreement or contract, implied or otherwise.

Physical Requirements: The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. May be required to lift and carry items.

Successful completion of a background check, criminal background, reference check and pre-employment drug test will be required for this position after offer of employment.

Pay based on experience

This position oversees one direct report.

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Quality Assurance Manager