Quality Assurance Compliance Coordinator

Kelly Science & Clinical is seeking a Senior Quality Assurance Coordinator near Cincinnati, OH.

Direct Hire

Shift: Monday - Friday 8am-5pm

Compensation: DOE

Reporting directly to the Senior Manager, Total Quality, the Quality Assurance Senior Compliance Coordinator will provide support to the Corporate Quality team by ensuring the company’s policies and practices meet regulatory requirements in a food, cosmetic, and pharmaceutical environment. The QA Senior Compliance Coordinator will be working directly with customers to complete or approve the customers’ regulatory product documentation including customer quality questionnaires about the company, product quality statements, process procedures, product stability study reports, etc.

This person will control, organize and maintain proprietary documentation for the company and customers. They will manage and maintain new QMS software system relative to position. The position utilizes extreme attention to detail to ensure that the documents reflect our quality program. The QA Senior Compliance Coordinator will also support the organization in other corporate quality programs including: quality internal and external auditing, document technical writing, product qualification practices, document control, quality and employee training.

This position will work with all levels of management and associates to facilitate problem-solving and ensure customer and regulatory quality standards are achieved.

• Completion and approval of customer quality documentation for site and product qualification (ie. Customer surveys, questionnaires).
• Creation and/or editing of product documents, procedures, supplier or service quality agreements, and other support materials. Produce electronic documentation in addition to hard copy manuals.
• Develop and maintain an electronic reservoir of up-to-date supplier product information. Maintain an organized filing system of original hard copy documents.
• Provide Corporate QA support to other CNA sites with customer complaints, investigations and reporting as requested.
• Navigate daily through customer specific software programs to update company’s specifications and product information.
• Ensure any quality software / electronic software systems are compliant with current regulations.
• Support Document Control program at all Company sites by reviewing, revising, and publishing procedures or forms. Route and obtain the specific approvals needed through electronic signature or manual wet signatures.
• Perform administrative functions to support the team including, preparing reports, document filing, proofreading, audit / meeting note taking, and correspondence.
• Provide training and education of the quality management system and practices to personnel as required for operational readiness activities.
• Work independently on assigned projects and daily QA maintenance functions.
• Serve as quality lead on the development and maintenance of Quality Management Systems (QMS) based on company’s global standards and regulations by collecting and analyzing data.
• Support on-site audits from customers and regulatory by taking notes in audits, preparing the audit response to customer, and providing supporting documentation.
• Complete assigned external audits with formal audit reports within a timely manner.
• Participates in Kaizen events, huddles, quality/safety walks, internal auditing, investigations, and 5S best practice events. Ensures that actions items are completed in a timely manner.
• Perform other administrative and quality assurance duties as assigned.

• Attention to Detail
• Organizational skills
• Good communication skills – verbal and written.
• Self-motivation, initiative
• Critical thinking.
• Working well independently as well as in a team.
• Determination and persistence.

• Bachelor’s degree or related discipline or equivalent combination of experience and education preferred.
• At least 4 years of progressive experience in a GMP manufacturing and / or laboratory environment.
• Worked in a GMP and ISO environment. Must have prior experience in a Quality Assurance role with knowledge of GDP requirements.
• GMP, GFSI,…