• Job Type:Contract

Posted 13 days ago

Job Description:

PURPOSE AND SCOPE OF POSITION:

• The Quality Assurance Label Control Specialist at the Devens Cell Therapy manufacturing facility is responsible for supporting site Label Control activities at Devens by Bristol Myers Squibb (BMS) policies, standards, procedures, and Global current Good Manufacturing Practices (cGMPs).

• Functional responsibilities include performing drug product label printing activities; ensuring accurate and timely issuance of labels for manufacturing and packaging labeling activities for Cell Therapy Development and Operations (CTDO).

• 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 and regulatory requirements and continuously improve its effectiveness and efficiency.

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; guides 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 them.

• 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 the department in internal and external cross-functional teams.

• Contributes to goals within the workgroup.

• 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 the facility

• • Candidates with experience working in secure restricted access facilities (in any industry) are preferred.

EDUCATION AND EXPERIENCE:

• HS diploma required. B.S. Degree preferred

• Minimum 2 years of relevant work experience

• Equivalent combination of education and experience is 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 within 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 markets, and other quality management activities as assigned.

• Provides support during internal and health authority inspections and audits of the 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.

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