Senior associate quality assurance job description

As part of the IT Quality team, ensure the delivery of technically robust and compliant GxP computerized systems (CS) that withstand audits, both internal and external. The Sr. IT Quality Associate II is expected to have working-level knowledge of CS at the enterprise level, including the quality systems supporting the implementation and management of enterprise systems (i.e., change management, exceptions management, risk management). The Sr. IT Quality Associate II is expected to have foundational understanding of regulatory expectations for CS and be able to provide quality oversight and guidance to IT teams to support implementation of and management of enterprise computer systems. This role works with peers locally and globally, to ensure practices are consistent with requirements and expectations set forth within the governing QMS.
What You'll Do

Drive the deployment of new GxP computerized systems through review and approval of life cycle deliverables in compliance with the governing regulations and procedures.

Ensures a state GxP audit readiness through compliant approval of Software Development Life Cycle (SLDC) documentation, validation testing, evaluation of IT Controls procedures, and continuous improvement activities

Perform and manage all supporting quality related activities associated with computerized systems including periodic reviews, exception management (deviation / CAPA), change management, risk management, etc. for assigned systems in alignment with noted KPIs.

Working with senior members of the team, represent ITQ on cross-functional teams in support of SDLC activities for GxP applications - either enterprise platforms or functional specific applications.

Support all Global Quality initiatives, including Data Integrity, Computerized Systems, and IT QMS implementation / remediation.

Who You Are

You are an experienced member of a QA organization with a BA/BS in Engineering or Life Sciences and a minimum of ten (10) years related QA experience and/or training with 5 years in a CSV / Quality role. You are passionate about compliance, have a keen eye for detail and are a strong communicator.

The Sr. Associate will be responsible for day to day activities related to product disposition including review of batch records and testing data, maintain applicable tracking and metric logs, attend CMOs meetings, general QA support for deviations and investigations and CAPA activities. In addition, he/she will be responsible for ensuring Sarepta's quality policies, practices, procedures standards, and systems for necessary adherence to aseptic production and product management in accordance to the cGXP compliance to US, ATMP and EU regulations are being maintained.

Review of batch records, testing data, and packaging/labeling from Contract Manufacturing Organizations (CMO) and Contract Testing LaboratoriesPerform lot disposition as applicable Track/maintain metric logs related to lot release and deviations/investigation Attend CMOs meetings as applicable to ensure resolution of batch record review comments or questions Represent QA on project teams as required Assisting in Investigation and deviation activities, and CAPAs, and providing general quality assurance support for the overall Quality System at SareptaScans approved documents to the QA files and, provide applicable approval documentation to CMOs.Assist with SOP writing and other QA activities as required Participate in external audit program as needed.Actively participates as a member of the Quality Ops Team and partners with the technical and analytical team.Perform data review, analysis, and identification of trends.Apprise senior management of critical issues.
Desired Education and Skills:
BS/MS or relevant/equivalent industry experience in scientific discipline preferred and 4-6 years of experience in a cGMP environment, with a focus on Lot Release, Product Disposition, Investigation/Deviation writing and reviewing Excellent organizational, interpersonal and communication skills Demonstrated proficiency and knowledge of cGMP (FDA and EU) and ICH requirements Experience in implementation and maintenance of quality systems Able to exercise judgment to determine appropriate corrective actions Candidate will be expected to interact CMOs and other groups across Sarepta.Detail oriented and the ability to communicate effectively, proactively and professionally to clients and members of the management team.Skilled in use of Microsoft Outlook, PowerPoint, Word, Excel and GMP system programs and spreadsheets is mandatory, as is a capacity to follow written procedures.Excellent written & verbal communication skills.Ability to travel domestically and internationally less than 10%

This position requires work on site at one of Sarepta's facilities in the United States. Candidates should be aware that Sarepta currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 in order to work on site. Newly hired employees must be vaccinated prior to their employment start date. Sarepta is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.

#LI-TG1

TCR2 has embarked on establishing a cGMP manufacturing operations to provide manufacturing capacity for Phase 1 and Phase 2 operations, and beyond, for the TRuCTM T cell platform. The Quality Assurance Sr. Associate will support quality operations under under the Quality Management System environment including product and batch record review, tracking training and deviations, change management, and assisting with documentation control activities. In addition, The QA Sr. Associate will support Research Operating Procedure development, document control and and tracking training for the non-GMP departments.
Responsibilities:

* Maintain quality supporting documentation to facilitate GMP production including tech transfers and equipment qualification/validation at CMOs.
* Perform review of manufacturing records and perform batch release for clinical lots.
* Manage Quality Change Control projects.
* Review Change Control records impacting T cell therapy product and provide QA support for other changes.
* Provide investigational support for deviations for the manufacture, testing, and shipping of raw materials or drug product.
* Write and revise quality SOPs and associated documentation to support GMP production.
* Support the quality vendor approval process for suppliers, contractors and service providers, and assist with external audits.
* Conduct training for GMP and GDP processing.
* Perform deviation review and implementation of CAPA to improve product quality.

Qualifications and Experience:

* Bachelor's degree in the biological sciences or related field.
* Minimum of 5 years GMP experience in a biotech, or biologics operation, or equivalent education/work experience.
* Knowledge of Quality Management System elements and experience in maintaining and improving systems supporting the QMS.
* Prior experience in a quality function (quality assurance or quality control), preferably in a commercial environment.
* Working knowledge and ability to apply GMPs in conformance with FDA, MHRA, EU and ICH standards, preferably gained from working in a manufacturing or QC environment.
* Good interpersonal, verbal and written communication skills.
* Comfortable in a fast-paced small company environment with minimal direction.
* External auditing experience preferred.