Quality Specialist

SummaryDo you enjoy puzzles? Is ‘identifying the core issue of a problem’ your thing? Do you have a natural attention to the most minute detail? Do you thrive in a fast-paced environment with the ability to pivot quickly with changing priorities? Then a career in Quality Assurance would be a rewarding opportunity. CalCog is hiring a Quality Specialist to ensure CalCog products and services are compliant with industry standards and regulations. This role is responsible for the execution of non-conformance management, training deployment, audit assist, general quality control tasks, and process improvement directives to increase efficiency and further promote quality integrity. Competencies, Traits, and Skills Must haves:· High level of independence and initiative, and an aptitude for attention to details, investigation, analysis, and problem solving.· Strong organizational skills/multitasking capabilities to support all CalCog projects concurrently and meet deadlines.· Strong interpersonal skills and the ability to manage, motivate, influence, and conduct quality work behaviors in self and others.· Flexible, enthusiastic, and highly motivated to work in a challenging environment.· Ability to comprehend complicated regulations and train on a vast variety of tasks of varying difficulty while applying GxP and company SOP knowledge at all times.· Confidence to initiate proper verbal and written communication between project team members/clients to ensure the timely delivery of project information, production records, and other quality centered communications.· Proficient knowledge of various computer applications to include Microsoft Office applications. Preferred candidates will possess: · Strong knowledge of QMS functions, including but not limited to: CAPA, change control, complaint, deviation, investigation, root cause analysis and good documentation practices.· Ability to apply professional knowledge and understanding of applicable regulations/company SOPs to ensure proper control of labels, labeling materials, packaging materials and randomization treatment group assignment.

Duties and Responsibilities· Ensure company compliance with GxP and SOPs for assigned tasks and responsibilities.· Maintain ongoing compliance with quality and industry regulatory requirements.· Interpret and implement quality assurance standards and procedures.· Assist with the maintenance of the CalCog QMS.· Provide quality support to CalCog globally and quality supervision for on-site operations requiring special attention.· Work with project management and clients (as needed) to provide quality solutions and feedback.· Investigate customer complaints, non-conformance issues (deviations), and quality incidents, and evaluate the findings to identify areas of improvement within the quality system.· Develop recommended corrective and preventative actions (CAPAs) to address identified gaps and monitor their implementation/effectiveness.· Organize/provide quality system training for new and existing personnel to improve compliance. Support the development and presentation of quality system training material.· Assist with the preparation, coordination, and execution of internal/external audits as well as the organizing, planning, and drafting of audit responses.· Maintain and monitor quality metrics by compiling monthly/quarterly/annual reports and assisting in the preparation of metrics for Quality Management Review meetings.· Participate in communication with prospective vendors, qualification of new vendors, and re- qualification of previously qualified vendors.· Assist with the review and release of receiving/distribution records, maintenance logs, and pre/post- production Batch Records (as needed).· Conduct quality inspections for received material/products and in-process goods.· Assist with the inspection/release of printed labels for production.· Participate in the handling of controlled substances in compliance with federal regulations.· Work with the Facilities Supervisor to ensure critical equipment is routinely maintained and calibrated.· Observe operations across the company to discover procedural gaps and areas of improvement.· Develop/adapt procedures and forms to improve the quality and efficiency of internal operations.· Implement and evaluate the effectiveness of process improvements, including providing training, performing in-process/document audits, and analyzing metrics.· Assist with the coordination and documentation of inter-department (cross) training as needed.· Provide training reports and updates to department managers and site leaders.· Generate periodic reports for open events within the eQMS (or similar) to department leaders.· Maintain oversight of internally assigned projects and tasks.· Other duties as assigned according to the changing needs of the business.

Qualifications and Experience: · Education: Bachelor’s Degree or the equivalent combination of education and related work experience in a GxP regulated employment setting totaling 1+ years. 3+ years of experience is required for consideration for a Specialist II.