Temporary Contract, 6 Months
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
- 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's and 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
Associated topics: automation, prevent, prevention, qa, quality assurance analyst, quality assurance engineer, software quality, software quality assurance, software quality engineer, test
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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