The QA Documentation Specialist shall develop, implement & maintain end-to-end Quality Assurance documentation.
Write, review, and implement company-wide deployment of Quality Assurance Documentation, including but not limited to -
Standard Operating Procedures (SOPs)
Work Instructions, Forms, Job Aids
Process Flows
Catalog and maintain all Manufacturing and quality documentation
Collaborate with cross-functional teams to identify areas of opportunity to develop necessary documentation, practices, and processes
Train cross-functional teams during the implementation of new procedures and practices
Perform and document product evaluations for conformance to listed specifications
Initiate and manage product non-conformances including but not limited to receiving and inspection, in-line and finished production and customer rejects/returns
Oversee the documentation of the Corrective Action Preventative Action (CAPA) lifecycle from initiation of root cause investigations through implementation of corrective actions
Digitalize production records and identify potential trends
Assist production, warehouse, and quality personnel as required
Perform timely escalations with strong communication skills across all levels of the organization
Passion for Quality and interest in the development of processes and documentation supporting a fast-paced manufacturing and production environment
Strong written and verbal communication skills in English. Proficiency in Spanish is a plus
Prior experience and knowledge in writing, developing, and implementing SOPs
Ability to prioritize and pivot daily activities driven by production urgency
Bachelor's degree from an accredited university and/or specialty in Technical Writing
Prior experience working in a regulated industry or liquid filling/manufacturing environment
American Society for Quality (ASQ) Certified Quality Inspector (CQI)
3 months: Formalizing company-wide documentation, while prioritizing SOP development including forms, job aids, work instructions, and process flows for Carson MFG.
6 months: Cross-train as a Quality Control Inspector to assist in receiving and inspections, and MFG QC Line checks. Coordinate the initiation of all Carson MFG NCRs and assist the Quality Supervisor in performing CAPA investigations when necessary.
12 months: Assist the Quality Supervisor in routinely maintaining and upkeeping Quality Dashboards and KPIs with minimal oversight. Identify and implement Quality Continuous Improvement initiatives supporting business needs.
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