Senior Specialist, Print Technician Team Lead

Job Description

Global Clinical Supply Operations is seeking a highly motivated individual to serve as a team lead in Print Technician Team.  The team lead will be responsible for coaching team members, managing team dynamics, and developing employees in the Print Technician group.

The team lead will be responsible to print and verify correct labels are produced according to clinical Good Manufacturing Practices (cGMPs). 

The successful candidate should have a working knowledge of clinical labeling, packaging and/or operations planning, including the understanding that all clinical supplies and associated documentation are processed according to Standard Operating Procedures, study protocols, Good Manufacturing Practice /Good Documentation Practice and appropriate company safety requirements to meet exacting standards defined by our company, the Food and Drug Administration (FDA) and European Union (EU) or other international regulatory agencies.

Key Responsibilities may include:

• Ensures that each component or bulk material used in label production is properly identified, not expired, verified throughout processing and corresponds to the written information on the work order before proceeding to the next step

• Print, inspect, proof, and perform accountability for clinical product labels.

• Maintain label inventory including discarding of expired material

• Acts as Qualified Trainer

• Carries out all the appropriate periodic quality inspections during the printing process to ensure the integrity

• Prepares shipments of labels to external packaging sites

• Receives bulk labels from booklet manufacturing vendors.

• Participate in equipment related testing and upgrades.

• Ensure other team members are performing tasks according to GMP and batch record instructions.

• Initiate and implement process improvements with the aim of increasing quality, customer satisfaction and efficiency.

• Monitor production schedule from a weekly, monthly and quarterly perspective while controlling group head count and employee utilization.

• Advance Operational capabilities by identifying new opportunities, seeking input from key stakeholders, and implementing ideas.

• Lead, promote, and support the use of innovation and technology in Label Production.

• Regularly evaluate employee performance, hold employee development discussions and conduct year end performance reviews.

• Manage Team, including problem solving and proactive escalation the next level management if needed.

• Lead local and global label projects (organize, host meetings, delegate tasks etc.)

• Author, review, and approve standard operating procedures and job aides for packaging and labeling activities.

• Participate and support internal and external audits

• Recommend process improvements in regular Operations meetings to enhance the efficiency of the Operations team

• Coordinate and Train new employees

Education: 

• Bachelor’s Degree or equivalent with four (4) years of relevant experience OR High School Diploma or equivalent with six (6) years of relevant experience Pharmaceutical Operations, preferably in a clinical supply related area

Preferred experience and skills:

• At least two (2) years of experience in management/leadership positions, required

• A minimum of six (6) years of relevant experience in supply chain or operations, preferred

• Ability to collaborate effectively, across functional boundaries, in multi-cultural environments to align stakeholders and drive tech transfer strategies/solutions.

• Demonstrated problem solving, effective verbal and written communication, and strong interpersonal skills.

• Strong understanding of clinical supplies and supply chain with relevant regulatory/GMP requirements.

• Ability to establish clear goals, delegate effectively, and hold self and others accountable

• Ability to succeed in a dynamic environment with flexibility to respond to changing priorities.

• Well-developed and effective team facilitation and leadership skills; ability to establish inclusive team environments.

• Proven project and team management skills

• Prior background with SAP is beneficial 

• Diligent and quality-oriented

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