Position Summary:
The QA Specialist II is responsible to ensure that production process is client focused, results oriented, performance driven, and in compliance with all applicable internal and external requirements. The QA Specialist II will compile the batch record review records and batch disposition documents required for GMP operation on timely basis.
Key Responsibilities and Duties:
- Provide QA oversight and support to client projects while working closely with QA Management to ensure QA support for GMP operations for the manufacture of master/working cell banks, bulk drug substance, plasmid products and/or final drug product used for human consumption
- Support Manufacturing and quality control departments in performing, and documenting deviations and failure investigations, including root cause analysis, evaluating product/facility impacts, and identifying/implementing effective corrective and preventive actions (CAPAs)
- Track and evaluate any non-conformances that occur during the manufacture of drug product and evaluate change controls as they impact the project
- Perform audits and/ or walkthrough of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and industry best practices
- Review executed batch production records and associated supporting documentation including logbooks, QC test reports, Environmental monitoring reports, cleaning records, etc.
- Compile batch disposition documentation timely for the final disposition of finished products
- Perform QA on the floor activities supporting client projects, including line clearance and room release, observing critical processes, reviewing documentation in real time, and resolving issues that occur during manufacturing
- Support raw materials review and disposition following approved internal procedure
- Receive and issue Batch Production Records and labels to manufacturing departments by verifying the accuracy and completeness from QA Document Control
- Ensure SOPs are current and effective, and staff performs routine tasks according to SOP through direct observation
- Review quality control test reports related to the execution of the batch processing
- Train Level 1 QA Specialists as required
- Drive continuous improvement and operational excellence culture through self-detecting and self-correcting processes and systems and instilling strong ownership and accountability
- Actively participate in all recruiting efforts to secure, onboard, and develop new staff members
- Evening and weekend hours may be needed to support production operations
- Additional duties as assigned
Qualifications:
- BS/ BA in life sciences or related fields
- Minimum 5 years of experience in GMP related experience in biopharmaceutical/ pharmaceutical or related industry
- Previous knowledge and experience with the practical implementation of FDA, EMA and ICH regulations and guidelines
- Previous experience in TrackWise Digital and Pilgrim is a plus
- Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges with poise, tact, and diplomacy
- Strong verbal and written communication skills
- Strong organizational skills; able to prioritize and manage through complex processes/projects
- Ability to define problems, collect data, and draw valid conclusions
- Ability to organize and disseminate information efficiently and multi-task in a fast-paced environment
- Organized, responsible, creative, pays attention to detail
- Knowledge of Microsoft suite (Word, Excel, Access, Vizio and PowerPoint)
- Able to follow instructions and Standard Operating Procedures
Job Types: Full-time, Contract
Pay: $20.00 - $25.00 per hour
Work Location: On the road
