Quality Assurance Specialist
Boston, MA Posted: 1/22/2020
GENERAL POSITION SUMMARY:
The Quality Assurance Specialist – QA Engineering is recognized as an expert internally in the principles and application of quality assurance and compliance related to GMP activities supporting Facilities, Utilities, Manufacturing and Laboratory equipment and instrumentation. The QA Specialist provides support and executes multiple tasks related to GMP activities supporting Facilities, Utilities, Manufacturing and Laboratory equipment and instrumentation. The QA Specialist adapts to new and multiple tasks, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements.
REQUIRED KNOWLEDGE, SKILLS, AND COMPETENCIES
Key Knowledge/ Skills and Competencies:
- Strong organizational skills with the ability to thrive in a high throughput environment
- Cross- functional collaborator
- Results Driver
- Collaboration / Teamwork
- Ability to work with cross-functional teams and represent the Quality unit
- Communication / Influencing
- Ability to effectively influence others within technical area of expertise
- Ability to communicate effectively across all organizational levels
- Critical Thinking / Problem Solving
- Ability to evaluate quality matters and make decisions utilizing risk based approach
- Flexibility / Adaptability
- Attention to detail
- Knowledge in the following areas:
- Global GMP requirements governing oral drug products and knowledge of oral drug product manufacturing practices
- Computerized Maintenance Management Systems – Maximo preferred
- Preventative Maintenance program and activities
- Metrology program and activities
- Validation program and activities
- Quality Control program including Environmental and Utility Monitoring
- Providing QA support and oversight of GMP manufacturing operation
- Working knowledge of equipment, facilities and utility system qualification activities in a cGMP setting
- Experience with event investigations, Root Cause Analysis (RCA), and CAPA
- Experience with network based applications such as Oracle and Trackwise preferred
- Primarily responsible with providing quality oversight and support to the Annex Drug Product Facility operation in the following key areas/activities – review and approval of documentation and activities related to engineering, validation/qualification and facilities and utilities support.
- Provide quality oversight of various site wide programs including the equipment and facilities maintenance, instrument calibration, periodic assessment, analytical equipment lifecycle, environmental and utilities monitoring, stability chambers trending, and alarm management.
- Provide support of facilities and engineering projects, including capital projects, annual plant shutdown, and various improvement projects as assigned.
- Provide on the floor support during testing and equipment/facility release, as required
- Responsible for tracking QA-Engineering performance metrics; including site metrics for change control.
- Participate in inspection readiness activities and provide support during regulatory site inspections. Lead compliance walkthroughs of the site and help drive the closure of any observations.
DESIRED EDUCATION AND EXPERIENCE:
• Demonstrated success independently working with cross-functional teams
• Experience with drug product (oral solid dosage forms preferred) development and manufacturing with proficient knowledge of the following in a pharmaceutical setting: cGMP'sand associated CMC regulatory considerations, experience with continuous manufacturing a plus.
• B.S in scientific or allied health field (or equivalent degree) and 3+years of relevant work experience
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