The Sr. Quality Specialist - QA Engineering is knowledgeable in the principles and application of quality assurance and compliance. The Quality Specialist supports or executes daily activities related to equipment or instrumentation supporting Facilities, Utilities, Manufacturing, and Labs. The Sr. Quality Specialist supports multiple projects, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements.
REQUIRED KNOWLEDGE, SKILLS, AND COMPETENCIES
Key Knowledge/ Skills and Competencies:
- Ability to thrive in a high throughput environment
- Collaboration / Teamwork / Conflict Management
- Ability to independently support cross-functional teams and represent the Quality unit
- Communication/ Influencing
- Ability to effectively influence others within technical area of expertise
- Ability to evaluate quality matters and make suggestions utilizing risk-based approach
- Attention to detail
- Knowledge in the following areas:
o Global GMP requirements governing oral drug products and knowledge of oral drug product manufacturing practices
o Knowledge of ASTM E2500, CSV/GAMP, and other associated standards
o Demonstrated ability to work independently to provide QA support for large, multifaceted projects
- Primarily responsible with providing quality oversight and support to VMC operations in the following key areas/activities; engineering, validation/qualification, facilities and utilities support.
Compliance Oversight of Internal Operations - QA Engineering
- Provide Quality oversight and review of calibrations, PMs, eCRs, work orders and laboratory operations via instrument qualifications
- Review and approval of qualification activities, and periodic assessments.
- Review and approval of trending programs (equipment, facility, utilities, etc.)
- Support EM and UM programs and control programs (Veriteq, pest control)
- Provide support of facilities and engineering projects, including capital projects, annual plant shutdown, and various improvement projects as assigned.
Compliance Oversight of Quality Systems
- Provide QA support of Equipment and Facility change controls, GMP investigations, associated CAPAs and Effectiveness Checks. Support collaboration with customers to ensure quality systems are monitored and established metrics are met.
- Responsible for monitoring and tracking performance metrics, trends; including site metrics for investigation/CAPA, Equipment and Facility Change Controls, etc.
- Responsible for biennial review and approval of department and cross-departmental processes for continuous improvement.
- Responsible for identifying risks and communicating gaps for GMP process/systems.
Audit / Inspection Support
- Participate in inspection readiness activities and provide support during regulatory site inspections. Provide post inspection support to address any regulatory observations.
Individual Development and Training
- Responsible for timely completion of trainings (100%),
REQUIRED EDUCATION AND EXPERIENCE:
- Demonstrated success independently leading cross-functional teams
- Experience providing QA support and oversight of GMP manufacturing operation
- Experience with drug product (oral solid dosage forms preferred) development and manufacturing with proficient knowledge of the following in a pharmaceutical setting:
o cGMP's and associated CMC regulatory considerations
o experience with continuous manufacturing a plus
- Experience with equipment, facilities and utility system qualifications activities in a cGMP setting, including change controls
- Experience with event investigations, Root Cause Analysis (RCA), and CAPA
- Experience with Veeva and Nuvolo preferred.
- B.S in scientific or allied health field (or equivalent degree) and 3+years of relevant work experience