Kelly Science, Engineering, Technology & Telecom · 2 days ago
Quality Assurance Compliance Coordinator
Cincinnati, OH
Full-time
Onsite
Mid, Senior Level
4+ years expKelly Science & Clinical is seeking a Senior Quality Assurance Coordinator. The role involves ensuring that the company’s policies and practices meet regulatory requirements in a food, cosmetic, and pharmaceutical environment, while also managing documentation and supporting the Corporate Quality team.
Staffing & Recruiting
Hiring Manager
Cristina Weed, MBA
Responsibilities
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 notetaking, 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
Qualification
Required
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, or ISO Certified Quality Auditor (ie ASQ). Able to perform supplier and service audits and write audit reports on behalf of company when needed. Familiar with customer and regulatory audits for excipients and pharmaceuticals, a plus
Internal Auditor certified. (ie. ISO 19011)
Intermediate computer literacy and software applications. Strong Computer skills of MS Office Suite, Quality Management Software (QMS) or Laboratory Management systems (LMS) systems
Proven Project Management skills
Able to present quality topics & learnings in large group settings
Proven technical writing skills and attention to detail in a scientific environment warranting such skills
Strong working knowledge of editing, proofreading, spelling, grammar, and punctuation
Skilled at organizing information into a clear and concise written form
Ability to work independently as well as in a team environment
Attention to Detail
Organizational skills
Good communication skills – verbal and written
Excellent time management
Self-motivation, initiative
Critical thinking
Working well independently as well as in a team
Being flexible
Determination and persistence
Being a quick learner
Project management skills
Preferred
Bachelor's degree or related discipline or equivalent combination of experience and education preferred
Experience in an ERP system, or Sharepoint software a plus
Company
Kelly Science, Engineering, Technology & Telecom
Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Linda Stuit
Senior Vice President, Engineering Specialty
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