Manufacturing Quality Assurance Analyst provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries Summary: The Manufacturing Quality Assurance (MQA) Specialist will be and essential part of the Business Unit’s management team. The MQA Specialist will assist in management of the daily activities of the Business Unit, but will report independently to the Manager of MQA. The MQA Specialist will be responsible for providing direct Quality Assurance support to the Manufacturing shop floor. The MQA Specialist, with direct supervisory guidance, will be responsible for a diverse and challenging set of activities, all of which are related to setting and maintaining quality standards aligned with US FDA cGMP and other applicable international GMP regulations and guidance’s. Essential Duties and Responsibilities:
• Performing line clearances and line monitoring.
• Having a basic knowledge of problem solving techniques and demonstrating the ability to troubleshoot with limited supervision.
• Verbally express ideas, facts and proposals that are clear, logical, and concise manner.
• Recognizing atypical data and reporting it to the appropriate supervisor or designee.
• Able to work effectively with other departments, coworkers, and QA teams.
• Being proficient at technically reviewing/auditing shop floor records and reports such as logbooks and other types of documentation for completeness and accuracy.
• Assisting MQA Analysts or MQA Senior Manager to identify technical problems and provide guidance and support to real time shop floor quality issues up to and including: making real time product impact assessments, and go no go decisions.
• Participating in quality systems implementation and maintenance efforts to ensure alignment with business process needs and user requirements.
• Awareness of changes impacting internal SOPs, recommending modifications for SOPs and author, review and edit documents, protocols, and problem reports.
• Working with the Quality Compliance and QAPS group to evaluate deviations related to production batches, the laboratories, or the facility.
• Working with the QA Product Specialists to support customer issues, investigations, corrective actions and change controls.
• QA operates 24 hours a day, 5 days a week for production support.
• The selected candidate will be required to support the graveyard shifts (B&D).
• Other duties as assigned. Supervisory Responsibilities:
This position will supervise the other graveyard MQA Analysts.
Education and/or Experience:
Bachelor’s degree (B. S.) & minimum of four years’ experience, preferably in an aseptic manufacturing environment. Language Skills:
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write clearly. Ability to speak effectively. Mathematical Skills:
Ability to apply basic math concepts. Reasoning Ability:
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Computer Skills:
Proficient in the use of MS Word, Excel, Outlook and Access, as this individual will perform work within these systems on a routine basis. Other Skills and Abilities:
• Excellent Communication skills, both verbal and written
• Ability to organize time in order to successfully manage multiple projects and priorities.
• Ability to lead.
• Ability to read, understand, interpret and implement technical writing and instructions.
• Effective inter-personal relation skills, while maintaining the adaptability to achieve company goals
• Verbally expresses ideas and facts in a clear, logical, concise and in accepted grammatical style.
• Willing to be on call to answer questions from production 24 hours/5 days a week.
• Root cause analysis trouble-shooting experience.
• Knowledge of aseptic processing technique.
• Ability to train and advice QA professionals and production personnel.
• Ability to assess and review all regulated product-specific documentation.
• Must pass background check.
• Must pass drug screen.
To apply for this job please visit pharmaboard.com.