Job Scope & Purpose:
Our client, a top Boston based biopharmaceutical company, is looking for a Principal Associate, Donation Quality to oversee the activities related to Donor Operations and Quality Assurance under GMP systems. Members of our client's team walk into work every day with the mindset that they are going to battle against a disease, and they won't stop fighting until they've found a cure. If you think that you can match this ambition then please keep reading!
Primary Job Responsibilities:
Provides Quality Assurance and oversight for Donation Collection Facilities and internal Operations, including assisting with the monitoring of a Quality Management System. Works closely with Donation Operations to develop and execute goals and objectives.
Provides quality guidance and support for Donation Collection Facilities and Donation Operation's projects and programs, ensuring compliance with regulations and internal policies.
Perform detailed record reviews to support the Certificate of Conformance for Starting Raw Material.
Assists with the Quality Process Review (QPR) Program. Participates in QPRs of donation collection sites, testing laboratories and donation operations activities to identify areas for improvement as well as best practices. Prepares QPR plans, checklists and summary reports. Works with QA Donation Operations Management to ensure follow up activities are completed.
Assists with investigations, corrective actions and tracking of Donation Operations and collection site deviations and CAPAs.
Manages documentation transition to archive, including but not limited to deviations, CAPAs, change control documents and logbooks.
Performs log book review for receipt and tracking of Starting Raw Material and associated retains.
Assists Donation Operations with SOP development embedding appropriate GMP requirements.
Assists with compilation of quality metrics.
Other duties as assigned including provide support to other quality groups as needed.
Occasional Travel required to sites for audits and record gathering.
Primary Job Requirements:
Bachelor of Science degree or equivalent in life sciences or engineering.
Minimum 8+ years of well-rounded Quality experience in the pharmaceutical or biotechnology industry including GMP internal auditing.
Experience in the preparation, conduct, reporting of audits and the translation of findings into effective corrective actions plans that mitigate risks to the company.
Experience in Batch Record Review, deviation/CAPA investigation, audit performance and reporting, and problem solving.
Demonstrated ability to effectively organize and execute tasks. Strong verbal and written communication (including presentation) and customer management skills.
ASQ Certified Quality Auditor (CQA) preferred.
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us at email@example.com or 877-787-2821.