We are specifically looking for candidates with hands-on experience of pharmaceutical stability storage and/or GMP-regulated stability operations. This is not a general warehouse, facilities or laboratory management position. Applicants should have direct experience working with stability chambers, stability samples and GMP-controlled processes within a pharmaceutical, biotech or similarly regulated environment. We are open to appointing at either Site Manager or Senior Stability Storage Technician level, depending on the experience of the successful candidate. Please make it clear in your application which level you are applying for. About the opportunity Astoriom provides specialist stability storage services to the pharmaceutical and life sciences industries, protecting and managing critical customer samples within highly controlled, regulated environments. We are looking to strengthen our team at our Hopedale, MA facility and are interested in speaking to experienced stability professionals at two different levels: Site Manager - Stability Storage For someone with strong stability/GMP experience who is ready to take overall responsibility for the operation of the Hopedale site, including its people, customers, quality, compliance and day-to-day performance. Senior Stability Storage Technician For someone with significant hands-on stability storage experience who wants to take a senior technical role within the operation, without necessarily having full site or people-management responsibility. For the right person, there may also be scope for the Senior Technician position to develop into broader site responsibility over time. What you'll be doing The exact responsibilities will depend on the level at which you're appointed, but will include a combination of: Managing stability samples, including receipt, storage, pulls, preparation and dispatch in accordance with customer protocols and SOPs Ensuring the integrity, traceability and security of customer samples Working with temperature-controlled stability chambers and associated monitoring systems Carrying out or coordinating routine equipment checks, servicing, calibration and maintenance Supporting equipment qualification and validation, including IQ, OQ and PQ Maintaining accurate GMP documentation and records Supporting deviations, CAPAs, change controls, alarms and out-of-condition events Participating in customer, internal and regulatory audits Monitoring chamber capacity and supporting contingency/disaster recovery arrangements Working closely with QA, customers and wider operational teams Driving high standards of safety, quality and continuous improvement. These responsibilities reflect the technical requirements of the role, including stability study schedules, validation, CAPA/deviation processes and environmental monitoring. For the Site Manager position In addition to the above, you would: Take overall responsibility for day-to-day stability storage operations at Hopedale Lead and develop the site team Ensure appropriate staffing, training and performance management Act as the senior site escalation point for operational, quality and compliance matters Take responsibility for site facilities and stability storage infrastructure Host and support customer, internal and regulatory audits Build strong relationships with customers and act as a key point of contact Work with commercial and operational colleagues on new opportunities, capacity and future site requirements Provide operational and capacity reporting to senior leadership. The Site Manager role therefore needs someone who can combine hands-on stability knowledge with leadership and operational ownership. The role also has a significant customer and commercial interface. What we're looking for Essential for either position: Previous experience working within pharmaceutical stability storage or a closely related GMP-regulated stability environment Strong practical understanding of GMP Experience working with temperature-controlled storage/stability chambers Good understanding of stability samples, documentation and controlled processes Experience working within SOPs and quality management systems Strong attention to detail and a high standard of documentation Confidence working in an audit-facing, highly regulated environment. Knowledge of FDA requirements, ICH stability guidelines, equipment validation, environmental monitoring, CAPA and deviation management would be particularly valuable. The existing Site Manager specification specifically requires strong GMP/quality systems knowledge and experience in regulated storage operations. For the Site Manager position, we're additionally looking for proven people leadership and the ability to take ownership of an operation, manage priorities and communicate confidently with customers and senior stakeholders. Applying We're deliberately keeping the level of this appointment flexible because finding the right stability storage experience is our priority. When applying, please clearly state whether you are interested in: Site Manager - Stability Storage or Senior Stability Storage Technician and highlight your specific experience of pharmaceutical stability storage, GMP environments and stability chambers. Applications without relevant stability/GMP experience are unlikely to be progressed.
Pay:
$65,000.00 - $90,000.00 per year
Benefits:
401(k) Dental insurance Health insurance Life insurance On-the-job training Opportunities for advancement Paid time off Vision insurance Application Question(s): When applying, please clearly state whether you are interested in: Site Manager - Stability Storage or Senior Stability Storage Technician and highlight your specific experience of pharmaceutical stability storage, GMP environments and stability chambers.
Experience:
stability storage/stability chambers : 3 years (Required)