The Quality Assurance Associate will be responsible for controlled documents and records at the HD Biosciences San Diego facility. Controlled documents may include SOPs (Standard Operating Procedures), memos, policies, and training records. The incumbent will also be responsible for document control, deviation and other non-conformances, CAPA, Equipment/Instrument associated systems, and Supplier Management.
Performs QA document control function, including document login, tracking, processing, approval, distributing, and archiving and has overall responsibility for document control processes.
Process all Document Control Requests (DCR's), assign document numbers, route and track the document review, approval and distribution.
Review document drafts for grammar, spelling and formatting and making corrections as needed for making documents effective for use.
Send out documents for periodic review requests to department heads
Maintain electronic folders of drafts, edits and approved/effective documents.
Maintain hardcopies of documents and update QA binders with current versions
Establish employee training matrix for all new employees, ensuring all training is completed and the training records are maintained and filed.
Maintains in house training programs including training matrix, training files, and audits of training files.
Assist with planning of internal and external audits to ensure compliance with current practices.
Help implement Supplier Management and CAPA processes
Train, support and advise end users on the Document Management System requirements and workflows.
Assist with other company administrative tasks as needed.
Experience / Education
Knowledge / Skills / Abilities:
Must have an understanding of documentation control systems and experience writing SOP's.
Expertise with MS Word, Excel, Office software.
Identify areas for improvement and make constructive suggestions for change
Experience with implementing and managing key Quality Management System processes (e.g., Change Management, Supplier Management, Deviations/CAPA, Management Review)
Excellent organizational skills and attention to detail.
Effective communication (both oral and written) required for interacting with all departments within the company as well as clients and outside agencies.
Must be able to think critically and independent problem solving capabilities
Must be a team player and have the ability to multitask across several areas
Ability to work in a fast paced environment and adapt to changes quickly
Must be able to work in environment with variable noise levels
Ability sit long periods of time
Ability to crouch, bend, twist, and reach
Clarity of vision
Must be able to perform activities with repetitive motions
Inside working conditions
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability