About the Company: A global Pharmaceutical company
Benefits: Real Staffing offers medical, dental, vision, 401K, voluntary life insurance, short term/long term disability.
About the Role: The 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 Quality Specialist supports multiple projects, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements.
Your Main Responsibilities:
Primarily responsible with supporting quality oversight to VMC operations in the following key areas/activities; engineering, validation/qualification, facilities and utilities support
Compliance Oversight of Internal Operations - QA Engineering
Review and approval of calibrations, PMs, eCRs, work orders and laboratory operations via instrument qualifications
Review and approval of change controls, 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.
May assist the QA Operations group activities such as area or line clearance.
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.
Support monitoring and tracking performance metrics, trends; including site metrics for investigation/CAPA, Equipment and Facility Change Controls, etc.
Support biennial review and approval of department and cross-departmental processes for continuous improvement. Support compliance walkthroughs of the site and help drive the closure of any observations.
Ability to identify risks and communicating gaps for GMP process/systems.
Support inspection readiness activities and provide support during regulatory site inspections. Provide post inspection support to address any regulatory observations.
Responsible for timely completion of trainings (100%), goal development, self-evaluation and IDP
Requirements
S in scientific or allied health field (or equivalent degree) and 3+years of relevant work experience
Knowledge in the following areas:
Global GMP requirements governing oral drug products and knowledge of oral drug product manufacturing practices
Knowledge of ASTM E2500, CSV/GAMP, and other associated standards
Demonstrated ability to work independently to provide QA support for large, multifaceted projects
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:
cGMP's and associated CMC regulatory considerations
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 Oracle and Veeva Quality Systems preferred.
EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
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