3296 Quality Associate

Duties:
Responsible for providing comprehensive technical support and quality assurance oversight to meet good manufacturing practices and the requirements of applicable Health Authorities and global policies. Supports the manufacturing, testing, disposition and distribution of Bulk Drug Substance and cross site participation on projects and initiatives.
Ensures that Oceanside product(s) consistently meets our customer and regulatory requirements.
Ability to process technical changes within the electronic Change Control system to assure proper technical SME review, assessment, approval and timely closure of all change records according to applicable quality standards and procedures.
Ability to provide comprehensive support, guidance, and coordination for Records Management and Document Management at the Oceanside Commercial Facility.

Job Responsibilities
Follow company policies and procedures.
Establish work priorities to meet targets and timelines.
Promote and provide guidance in Good Documentation Practices.
Serve as a point of contact for Records Management, including inventory of documents, archival, cross-functional support, and organization of documents in the QA Vault.
Serve as a liaison to coordinate, facilitate or manage Records Management projects with other departments.
Responsible for the coordination of the end to end process of changes for QA controlled documents impacting GMP equipment, facilities, utilities, and QC in the various forms utilizing electronic systems such as Trackwise, Electronic Document Management System (EDMS), etc.
Create and revise QA controlled procedures, department job aids, and/or training for Document and Record Management site users in an EDMS.
Develops relationships with customers for support of records and document management.
Coordinate scanning of Records contained in the QA Vault, as needed.
Function as a Change Controller by assessing, reviewing, approving and closing change records, as needed.
Report any non-compliance of GMP throughout all applicable areas and functions when observed.
Seeks guidance to address potential Quality issues and resolutions.
Follows established safety and environmental guidelines and procedures for all work performed.
Immediately report safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions.
Ability to work with customers and discuss record and document management topics physically in Manufacturing cleanroom areas, laboratories, or other areas to provide guidance for Quality requirements.
Attend training sessions, as required.

Skills:
Advanced ability with various computer systems and experience using Microsoft applications, google applications, and electronic document management systems.
Knowledge and experience with electronic system for document submissions, document retrieval and archival.
Operate office equipment such as a computers, printers, scanner, etc.
High interaction across functional areas either by email, phone, or face-to-face.
Commitment to quality and pride in work.
Detail oriented.
Must be flexible; able to manage changes in priorities and frequent interruptions.
Strong knowledge of Good Manufacturing Practices, Standard Operating Procedures, Quality Systems, and general compliance principles.
Knowledge and overall understanding of biopharmaceutical manufacturing and manufacturing support processes.
Working knowledge of FDA requirements for GMP compliance.
Familiarity with continuous improvement principles.
Ability to work as part of a team and collaborate effectively with team members.
Able to work effectively in a customer service role.
Excellent communication skills, both written and verbal.
Must understand Quality standards and policies, cGMPs, Health Authority Regulations Excellent communication skills, verbal and written.
Strong knowledge of Good Manufacturing Practices, Standard Operating Procedures, Quality Systems, and general compliance principles.
Knowledge of cGMP regulations applicable global regulatory agencies.
Demonstrated ability to manage multiple activities while maintaining a high level of organization.
Demonstrated ability to work as part of a team and collaborate effectively with staff at all levels.

Education:
B.A. or B.S. degree (preferably in Life Science).