Senior Qa Specialist - Operations

Job Summary

The Senior QA Specialist 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 Senior QA Specialist will compile the batch record review records and batch disposition documents required for GMP operation on timely basis.

This includes but is not limited to the following:

• Reviews deviation investigation reports for accuracy and adequacy of root cause analysis and CAPA identification.
• Supports 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).
• Reviews executed batch production records and associated supporting documentation including logbooks, QC test reports, Environmental monitoring reports, cleaning records, etc.
• 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.
• Supports raw materials review and disposition following approved internal procedure.
• 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.
• Performs 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.
• Actively participates in all recruiting efforts to secure, onboard, and develop new staff members.
• Evening and weekend hours may be needed to support production operations
• Ensures SOPs are current and effective, and staff performs routine tasks according to SOP through direct observation.
• Track and evaluate any non-conformances that occur during the manufacture of drug product and evaluate change controls as they impact the project.
• Conduct training for QA and cross-functional team members as required.
• Reviews quality control test reports related to the execution of the batch processing.
• Additional duties as assigned.
• Receives and issues Batch Production Records and labels to manufacturing departments by verifying the accuracy and completeness from QA Document Control.
• Drive continuous improvement and operational excellence culture through self-detecting and self-correcting processes and systems and instilling strong ownership and accountability.
• Compiles batch disposition documentation timely for the final disposition of finished products.

Job Qualifications

• Previous knowledge and experience with the practical implementation of FDA, EMA and ICH regulations and guidelines.
• Ability to work on complex problems of diverse scope and collect data to draw valid conclusions.
• Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges with poise, tact, and diplomacy.
• Ability to follow instructions and Standard Operating Procedures.
• Strong organizational skills; able to prioritize and manage through complex processes/projects.
• BS/ BA in life sciences or related fields.
• Ability to multitask effectively.
• Ability to organize and disseminate information efficiently and multi-task in a fast-paced environment, organized, responsible, creative, pays attention to detail, multi-tasker.
• Knowledge of Microsoft suite (Word, Excel, Access, Vizio and PowerPoint).
• Ability to exercise sound judgment within defined procedures to determine appropriate actions for resolution of manufacturing or laboratory issues.
• Ability to always maintain a professional and pleasant demeanor.
• Previous experience in TrackWise Digital and Pilgrim is a plus.
• Strong verbal and written communication skills.
• Minimum 7 years of experience in GMP related experience in biopharmaceutical/ pharmaceutical or related industry, with 3 years of direct experience in batch record review and batch disposition.

The pay range for this position is $97000-$110000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.