Ensures compliance with all regulatory standards, systems, procedures and practices. Includes cGMP, GLP, CLIA, CE, ISO, EU and other regulatory requirements and agencies as it relates to Quality Assurance activities in the manufacturing and testing facility.
Applies a good working knowledge of cGMP, ISO and other regulatory requirements and agencies as it relates to Quality Assurance activities in a manufacturing environment through support of manufacturing operations including staging, line inspections, batch record issuance, batch record review and material release.
Conducts internal and external audits, summarizing the results and providing summaries to Quality Management.
Oversees the Document Change Control Process, NCR, CAPA, Complaints and OOS systems.
Reviews and approves validation activities.
Assists in the administration of the CAPA and investigation programs; including identification, data generation, summarization and closure.
Assists in the maintenance of controlled documents, including creation, editing, indexing, tracking and storage using the Microsoft Office Sharepoint Server System or other Electronic Document Management System.
Reviews and approves quality equipment calibrations and maintenance.
Manage the historical files of all manufactured products and archival records including on and offsite storage.
Supports regulatory and client audits.
Supports the overall Quality goals and QA Department goals.
Generates metrics in support of Quality Management Reviews. =623;\
All other duties as assigned.
Minimum Education/Experience Requirements:
Bachelors/Master’s degree in a related field from an accredited four-year college or university, 2to 4 years of experience in a regulated manufacturing facility; or a combination of educational and applicable work experience.
Preferable Skills and Attributes:
Skilled in the use of software programs such as Microsoft Office and database management programs.
Detail oriented and skilled at examining documents for accuracy and completeness. Ability to prepare records in accordance with detailed instructions.
Knowledgeable in QA principles and concepts in a dynamic manufacturing facility
Ability to set priorities and meet deadlines on a personal level. Ability to work under tight deadlines.
Capability to effectively train employees on procedures, processes and QA concepts.
Team oriented individual with the ability to work effectively with multiple skill level employees. Skilled at dispute resolution.
Excellent written and oral communication skills.
Excellent analytical and problem solving skills with the ability to work independently with minimal supervision.
Familiarity with statistical tools and concepts and their application in a regulated environment.
Knowledge of cGMP, ISO, OSHA, CE, IVD preferred.