Quality Assurance (QA) Compliance Specialist III - US Tech Solutions, Inc.
Worcester, MA 01605
About the Job
• Monitors compliance with all policies and procedures in addition to all federal/state/local/global and pharmaceutical laws and regulations.
• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility.
• Ensure investigations of plant events are completed thoroughly and documented accurately and are included in the plant CAPA system. Perform product impact analyses for plant events and places product on QA hold where appropriate.
• Supports investigations and provides metric collection for timely resolutions to exceptions events, out of trend events, facilities and document Risk Management activities (e.g. FMEA).
• Develops QA training programs for various processes and may provide training to departmental personnel.
• Provide support in defining statistical design and analysis for process development, technology transfer, analytical development, process validation and re-qualifications, manufacturing, chemistry and microbiology laboratories, incoming QA, investigations, CAPA’s, compliance, complaints process.
• Manage QA lists, spreadsheets and databases as required by site operations.
• Evaluates, analyzes and trends quality indicators.
• Prepares reports of quality operations, productivity as well as monthly quality metrics.
• Prepares QA presentations suitable for management and external customers.
• Participates in Improvement initiatives and assures quality compliance.
• Support change control activities
Requirements:
• Bachelors degree, preferably in Science or Engineering or equivalent related work experience.
• 5 to 10 years experience
• Knowledge of applicable regulations and standards affecting Pharmaceutical Products (e.g. CFR 210/211, cGMP, DEA) and CGMP environments.
• Strong analytical skills, ability to analyze data, trends and draw conclusions.
• Computer skills, especially with Excel, PowerPoint and Visio programs to create automated metrics and visuals.
• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility.
• Ensure investigations of plant events are completed thoroughly and documented accurately and are included in the plant CAPA system. Perform product impact analyses for plant events and places product on QA hold where appropriate.
• Supports investigations and provides metric collection for timely resolutions to exceptions events, out of trend events, facilities and document Risk Management activities (e.g. FMEA).
• Develops QA training programs for various processes and may provide training to departmental personnel.
• Provide support in defining statistical design and analysis for process development, technology transfer, analytical development, process validation and re-qualifications, manufacturing, chemistry and microbiology laboratories, incoming QA, investigations, CAPA’s, compliance, complaints process.
• Manage QA lists, spreadsheets and databases as required by site operations.
• Evaluates, analyzes and trends quality indicators.
• Prepares reports of quality operations, productivity as well as monthly quality metrics.
• Prepares QA presentations suitable for management and external customers.
• Participates in Improvement initiatives and assures quality compliance.
• Support change control activities
Requirements:
• Bachelors degree, preferably in Science or Engineering or equivalent related work experience.
• 5 to 10 years experience
• Knowledge of applicable regulations and standards affecting Pharmaceutical Products (e.g. CFR 210/211, cGMP, DEA) and CGMP environments.
• Strong analytical skills, ability to analyze data, trends and draw conclusions.
• Computer skills, especially with Excel, PowerPoint and Visio programs to create automated metrics and visuals.
Source : US Tech Solutions, Inc.