*This opportunity is supporting our MA and FL clients. We are currently offering relocation assistance and Visa sponsorship to all qualified individuals. *
The Senior Quality Assurance Specialist supports the day-to-day quality operations of all elements of the Quality Management System (QMS), including but not limited to deviations, Corrective and Preventive Actions (CAPAs), investigations, excursions, Out of Specifications (OOS), change control, batch review and disposition, and data integrity with a focus on quality engineering and validation aspects of biologics manufacturing production.
- Perform reviews of Validation Lifecycle documents including, but not limited to, Functional, Detailed Design, Configuration and User Requirement Specifications (FS/DDS/CS/URS) and Factory and Site Acceptance Test (FAT/SAT) protocols and Reports from a quality perspective to ensure compliance to internal requirements.
- Perform reviews of protocols and reports relating to Facilities, Utilities, and Equipment commissioning and qualification/requalification, process/method validation, and other cGMP activities from a quality perspective to ensure compliance to internal requirements and sound technical rational.
- Review and approve deviations and CAPAs; including performing Failure Mode Effect Analyses (risk assessments), participating in root cause analysis investigations, evaluating CAPA effectiveness, and oversight of departmental training.
- Review and approve change controls with a focus on those pertaining to equipment, facilities, utilities and process changes ensuring validation impact, procedural impact, regulatory impact, and prescribed testing is adequate and well justified.
- Perform the review and approval of commissioning and qualification documentation for facilities, equipment, and utilities.
- Review and approve preventative maintenance, calibration, and work order documentation.
- Support internal and external audits.
- Support the supplier quality program through review and approval of vendor change notifications, part number requests, raw material specifications, and raw material release.
- Represent Quality Assurance on project teams and in meetings.
- Support the continuous improvement and oversight of Quality Management System procedures.
- Provide any additional QA support as necessary (e.g. Review and approve batch records).
Skills & Qualifications
- A minimum of a bachelor's degree.
- 4-8 years of relevant GMP experience in pharma/biotech company, working within a quality system and regulated GMP environment
- Experience working in a GMP manufacturing environment
- Well versed in cGMP/ICH/FDA/EU regulations and guidelines
- Proficient in using Microsoft applications (MS Word, MS Excel, MS Powerpoint)
DPS Group is a global EPCM firm offering full-service solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) industries. DPS is dedicated to delivering successful projects with a client-first' mentality and personal touch across a range of market sectors: Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start-up.
DPS Engineering Inc. is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. DPS does not discriminate in employment opportunities or practices on the basis of: race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status or any other characteristic protected by country, regional or local law.