Quality Assurance Specialist II

Job Description

Job 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.

Duties an Responsibilities:

• 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.