Our client, a leading pharmaceutical company, is hiring a QA Document Control Labeling Specialist on a contract basis.
The Quality Assurance Label Control organization is responsible for the establishment, maintenance and continuous improvement of the clinical and commercial label control process, procedures, and responsibilities for achieving quality policies and objectives. This organization supports the Devens facility to ensure patient safety, regulatory requirements and improve its effectiveness and efficiency on a continuous basis.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
• Knowledge and experience with GMP, Quality, and compliance preferred.
• Able to write and review technical reports with clarity and brevity; provides guidance to other team members in technical writing skills.
• Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
• Must be organized and possess an independent mindset.
• Good understanding of electronic document management and manufacturing execution systems.
• Demonstrated proficiency with PC-based office computers and standard Microsoft Office applications.
• Confident in making decisions for non-routine issues.
• Routinely recognizes and addresses quality opportunities to improve overall process/project efficiencies.
• Proposes solutions for complex issues and works with management to resolve. Follows established procedures and performs work as assigned.
• Builds relationships and effectively communicates internally within the function and with internal and external cross-functional teams. Interacts with internal and external cross-functional teams. Represents department in internal and external cross-functional teams.
• Contributes to goals within the work group.
• Able to recognize conflict and notify management with proposed recommendations for resolution.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Able to produce data reports with precision.
• Able to support internal and health authority inspections of facility
* Candidates with experience working in secure restricted access facilities (in any industry) preferred.
EDUCATION AND EXPERIENCE:
HS diploma required. B.S. Degree preferred
Minimum 2 years relevant work experience
Equivalent combination of education and experience acceptable
DUTIES AND RESPONSIBILITIES:
• Supports all activities for the Quality Assurance Label Control group.
• Responsible for issuing clinical and commercial final product labels for product batches during specified work hours, which regularly include scheduled nights, weekends and holidays. Scheduled operations are subject to change occasionally with approximately 48 hours notice due to the nature of Cell Therapy. Work hours outside of scheduled primary operations are extremely flexible.
• Responsible for ensuring accurate printed information on labels in compliance with health authority requirements.
• Coordinates with production teams to ensure timely issuance of labels.
• Performs training of label control and issuance requirements for internal personnel as needed.
• Ensures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks, etc. Writes, reviews and updates SOPs as required.
• Carries out plans and actions to support new drug product launches, new market and other quality management activities as assigned.
• Provides support during internal and health authority inspections and audits of facility.
• Knowledge of quality processes, including label control and issuance, change control, product complaints, deviations, investigations and Corrective Action/Preventative Action (CAPA) management.
• Performs supplemental investigations/projects as required by Management.
• Maintains knowledge of cGMPs and regulatory guidelines.