PURPOSE AND SCOPE OF POSITION:
The Quality Assurance Label Control Specialist at a Cell Therapy manufacturing facility is responsible for supporting site Label Control in accordance with policies, standards, procedures and Global cGMPs.
DUTIES AND RESPONSIBILITIES: This position is scheduled for Wed- Sat (4:00 pm-2:00 am).
- Supports all activities for the Quality Assurance Label Control group.
- Responsible for issuing clinical and commercial in-process and final product labels for labeling operations.
- 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.
REQUIRED COMPETENCIES:
- Minimum of 1 year of relevant labeling experience in a cGMP/FDA regulated environment preferred
- Some document management experience.
- Crystal reports and BarTender experience required.
- Strong communication and customer service skills.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.