Quality Assurance Manager
The Quality Assurance Manager is a highly dynamic individual who supports daily operations, best in-class quality practices, and continued growth. The Quality Assurance Manager manages activities related to cGMP manufacturing, packaging, testing, and storage, as well as participating in relevant audits. The Quality Assurance Manager works directly with Operations, Engineering, Distribution, R&D, Marketing, Sales, and other team members, to ensure the quality management system (QMS) is organized, efficient, and compliant with with all relevant regulations and business policies/practices. The Quality Assurance Manager is a highly dynamic and motivated team player who can operate independently with minimal supervision.

Essential Duties & Responsibilities
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Executes and supports the strategic direction of Quality to ensure the production of high quality, safe, and legally compliant products that meet customer expectations.

• Stays current with regulations and changes to guidance document.

• Creates, updates, and maintains master documents in accordance with all relevant quality policies, regulations, and procedures.

• Maintains document control function with appropriate processes, procedures, and practices.

• Requests and reviews qualification documents from contract manufacturers, distributors, and raw material suppliers.

• Qualifies existing and new suppliers, in collaboration with Sourcing organization, according to internal SOPs.

• Ability to manage multiple projects and changing priorities.

• Ability to rapidly learn new systems and procedures.

• Lead change through effective communication and persuasion skills.

• Excellent attention to detail and ability to effectively plan, organize and prioritize workload.

• Collaborates with R&D and Mfg. Engineering on the creation of validation protocol, to include involvement in the validations, oversight of the processes and results and approval of the final protocol.

• Engages the production organization efficiently and routinely to resolve quality issues related to products, processes, equipment, or other.

• Provides direction to their team and the production team on QA/QC requirements to ensure compliance is achieved collaboratively.

• Interfaces directly with customers to support quality-related customer requests for documentation and resolves customer-initiated quality issues.

• Responsible for oversight of documentation management system for customer documentation.

• Responsible for data review, COA creation, and related documentation management for the testing and release of raw materials and finished products.

• Implements in-process product inspection standards by studying manufacturing methods and devising testing methods and procedures. · Establishes standards for the disposition of finished product by devising evaluation tests, methods, and procedures.

• Institutes rework standards by devising inspection and physical testing methods and procedures.

• Partners cross-functionally to ensure raw materials (RM) and finished goods (FG) stability studies, testing programs, sample retention program meet appropriate quality standards and regulatory requirements.

• Supports investigations such as complaints, deviations, Out-of-Specs, conducts root cause analysis, and leads documentation and escalation of quality issues to ensure timely and effective issue resolution.

• Analyzes production data to identify trends and collaborates with Operations and Engineering to recommend updates or changes to quality standards and procedures to drive continuous quality improvement and optimize business processes.

• Reports on KPIs to track performance including customer satisfaction levels and vendor compliance.

• Partners with Sourcing and R&D on RM and FG supplier-management efforts to ensure they meet established policies and regulations.

• Participates in internal and external audits against relevant GMP regulations.

• Stays current with regulations and changes to guidance document.

• Maintains department staff reviews and annual performance goals.

Education and/or experience
The preferred candidate should exemplify the following characteristics:

• 5+ years of experience in Quality Assurance,

• B.S. in sciences, engineering, or technical fields.

• Direct experience in manufacturing

• Act as a coach and mentor to their team and others.

• Working knowledge of quality systems

• Exceptional verbal and written communication skills

• Devoted to high-quality standards and scientific excellence.

• Takes initiative, accountability, and ownership for job responsibilities and professional development.

• Thinks expansively beyond role to support colleagues and make the business run efficiently.

• Commercially minded leader and team player.

• Proficiency in MS office suite

• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or government regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the regulatory bodies.

• Ability to work with mathematical concepts such as probability percentages, ratios, and proportions to practical situations and statistical inference. Ability to apply concepts such as fractions.

• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.

• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

• Knowledge of statistical software (Minitab), ERP system software, and digital quality management software are preferred.

• Knowledge of Microsoft Office is required.

• Preferred but not mandatory: Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Certified Quality Manager (CQM).

If you are interested in this opportunity please apply to this job posting so we can review and contact you with next steps to discuss your career search.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.