Director Quality Assurance (On-site GMP)
Location: Watertown, MA
On-site Requirement
HireMinds is seeking your expertise in Quality as an experienced Associate Director/Director of Quality Assurance to lead quality programs in a dynamic cGMP clinical-stage manufacturing environment. In this role you'll work with an on-site presence in the support of production of cutting-edge radiopharmaceutical therapies for unmet needs in oncology. You'll work with a tight-knit biotech team with backing from pharmaceutical partners. If this sounds like an exciting opportunity to further your career apply today or contact the HireMinds Biotech team.
You'll Be Responsible For:
* Operational QA Support: Provide onsite QA oversight for aseptic drug product manufacturing, including drafting and reviewing batch records, releasing raw materials and finished products, and managing deviations, CAPAs, and change controls.
* Metrology Program Support: Develop and review IQ/OQ/PQ documentation for instruments, equipment, and facilities. Oversee scheduling of vendor qualifications and preventive maintenance.
* GxP Training: Design and deliver GxP training programs (GMP, GCP, GLP, CSV), manage training records, and assign curricula.
* Quality Management System (QMS): Develop and review SOPs related to quality assurance, manufacturing, and quality control.
* Auditing & Vendor Management: Conduct internal GxP audits, source data verification, vendor qualification assessments, and risk evaluations.
* Regulatory Compliance: Support regulatory submissions by reviewing technical documents such as technology transfer protocols, process validation reports, and stability studies.
* Metrics & Reporting: Collect and report quality assurance metrics during Quality Management Review meetings.
* Documentation Management: Maintain electronic and paper-based archives of quality documents.
You'll Bring With You:
* BS/MS in engineering or scientific manufacturing disciplines.
* Minimum 5 years in cGMP aseptic manufacturing and quality control within the pharmaceutical or biotech industry.
* Familiarity with global QMS standards (e.g., EU GMP Vol 4, Annexes 1 & 3, 21 CFR 210-212, Part 11, ICH, USP).
* Experience in QA for GCP, GLP, CSV compliance, or radiopharmaceuticals is a plus.
* Strong cross-functional collaboration abilities.
* Commitment to data integrity and adherence to compliance requirements.
* Passion for making an impact in the oncology field for patients in need.
*
HireMinds LLCLead Art Handler/Installer Department: TruckingEmployment Type: Full TimeLocation: Los AngelesReporting To: Dispatch ManagerCompensation: $25.00 - $33.00 / hourDescription To assist with all aspects of removals, collections, deliveries and installations of personal...
...Job Description Job Description SOLAR INSTALLER Starting Pay: $23 - $27/hr. Responsibilities: Maintain compliance with all... .... Assemble and install the support structure for solar PV panels according to building codes, manufacturing specification and...
...years of age. Schedule : Monday - Friday, 8 am - 4:30 pm We are looking for a Mental Health Professional who: Meet MA Early Intervention Operational Standards in relation to educational and experience requirements. Early Intervention policies | Mass.gov...
...Class A Truck Driver at US Foods, Inc. summary: As a Class A Truck Driver at US Foods, you will be responsible for delivering food products to customers with excellent service while maintaining scheduled delivery times. This role necessitates a valid CDL Class A license...
...includes assigning you a formal mentor and interactions with senior executives. What you can expect in this role As a Spectrum Intern, youll be essential to two teams your respective department and your Intern peer group. Department and team-focused projects...