Position Requirement Overview: QA Documentation Specialist
The QA Documentation Specialist shall develop, implement & maintain end-to-end Quality Assurance Documentation
Position Description:
Write, review, and implement company-wide deployment of Quality Assurance Documentation, including but not limited to –
o Standard Operating Procedures (SOPs)
o Work Instructions, Forms, Job Aids
o Process Flows
Collaborate with cross-functional teams to identify areas of opportunity to develop necessary documentation, practices, and processes
Train cross-functional teams during implementation of new procedures & practices
Perform & document product evaluations for conformance to listed specifications
Initiate & manage product non-conformances including but not limited to receiving & inspection, in-line & 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 organization
Required Skills:
Passion for Quality and interest in development of processes & documentation supporting a fast-paced manufacturing & production environment
Strong written & verbal communication skills in English. Proficiency in Spanish is a plus
Prior experience & knowledge in writing, developing, and implementing SOPs
Ability to prioritize & pivot daily activities driven by production urgency
Preferred:
o Bachelor’s degree from an accredited university and/or specialty in Technical Writing
o Prior experience working in a regulated industry or liquid filling/manufacturing environment
o American Society for Quality (ASQ) Certified Quality Inspector (CQI)
