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Job Title: Quality Control Specialist

Location: Norwood, MA

Work Arrangement: 100% Onsite

Job Description:

The Quality Control Stability Specialist will play a key role in supporting US and Global processes for harmonizing and integrating Commercial and Clinical stability-related activities. This position involves leading, owning, and supporting various GMP stability testing programs and Quality Systems. Key responsibilities include creating, implementing, and maintaining stability databases, performing data trending, managing Quality Events from initiation through closure, reporting metrics, conducting statistical analysis, and creating SOPs, stability protocols, and reports in compliance with current GMP, FDA, EU, and ICH guidelines and regulations.

Additionally, the individual in this role will assist in leading and maintaining stability-related processes, equipment, and systems at the Norwood, MA location. Some travel between site locations may be required, and weekend and holiday support may be necessary, including a combination of remote and onsite work as needed.

Key Responsibilities:

• Support and conduct trending and statistical analysis following stability program SOPs and ICH guidelines.
• Create, review, and revise stability protocols, reports, and specification documents through the initiation of document change requests.
• Initiate and manage stability studies in LIMS, and perform data entry and review as necessary.
• Ensure proper organization and maintenance of stability chambers and walk-ins, and assist with troubleshooting and interpretation of temperature chart (Pi) data.
• Support maintenance, calibration, and operation activities for stability chambers, including unit performance.
• Create, maintain, and assist with accurate inventories for all GMP Stability drug substances and drug products received, stored, and removed for testing.
• Develop and maintain stability schedules for GMP stability drug substances and drug products, ensuring stability sample pulls occur as scheduled and within appropriate timelines.
• Coordinate and support the shipment of samples to external labs for testing and/or storage based on stability pull schedules.
• Assist with stability pulls and set downs.
• Compile metrics in support of quarterly QMR, stability meetings, and investigations.
• Initiate and close Quality Events, including Deviations, laboratory investigations, CAPA, and Change Controls.
• Support stability team meetings.
• Request and retrieve stability testing data/reports from external vendors and update shared site folders, including stability data tables and LIMS.
• Provide support for applicable stability sections of regulatory submissions.
• Assist with Reference Standard and Cell Bank Stability Program management.
• Participate in continuous improvement activities for the stability program.
• Ensure compliance with cGMP and safety requirements.
• Participate in audits as needed.

Qualifications:

• Bachelor's degree with a minimum of 4 years of Quality Control experience in a Commercial/Global cGMP Quality Assurance/Quality Control Biotech or Pharma setting, with a focus on Stability for at least 3 years.
• Strong knowledge of relevant EU and global regulations and ICH standards/guidelines, including experience in participating in successful regulatory inspections related to stability.
• Proficiency in managing Quality System Records, Deviations, Change Controls, and CAPAs.
• Knowledge of clinical and commercial GMP QC stability.
• Familiarity with statistical analysis programs and software, e.g., JMP, Looker, Tableau, Statistica/Spotfire for trend analysis and reporting of stability data and metrics.
• Experience with electronic databases such as LabVantage LIMS, LabAccess, Fusion, and Veeva is preferred.
• Proficiency in MS Office programs (Outlook, PowerPoint, Excel, Word).
• Experience working with worldwide CROs, vendors, and relationship management is a plus.
• Strong organizational skills and the ability to manage multiple projects and tasks in a fast-paced environment.
• Excellent communication skills, both verbal and written.
• Ability to work independently and effectively troubleshoot and communicate issues.
• Experience collaborating in a dynamic, cross-functional matrix environment.
• Familiarity with Reference Standard and Cell Bank Stability Programs.

To apply for this position, please submit your resume and a cover letter outlining your qualifications and experience to careers@unitedpharamtechnologies.com(link removed) If you meet the qualifications and are ready to contribute your expertise to our team, we encourage you to apply for this exciting opportunity.