Search for Quality Assurance Label Control Specialist roles in Summit, NJ, with at least 2 years of experience in cGMP environments, and strong knowledge of labeling processes and quality management, ideally in Biopharma.

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Quality Assurance Label Control Specialist

Summit, NJ

2 years + Experience

cGMP

Biopharma

Can you help me to analyze the job description and company culture?

Sure. Here's the analysis:

Job Analysis:

The role of the QA CTO Label Specialist at Bristol Myers Squibb is fundamentally rooted in ensuring adherence to quality standards for labeling processes in a fast-paced manufacturing environment. This position is critical in supporting label control activities that are compliant with client policies, regulations, and global cGMPs. A successful candidate will take on responsibilities that include issuing accurate clinical and commercial labels, training staff on label processes, and maintaining standard operating procedures. The position requires both proactive communication with production teams and the technical writing of SOPs, reflecting the need for precision and clarity in regulated documentation. Candidates will likely face challenges in navigating regulatory demands while also optimizing process efficiencies, highlighting the importance of problem-solving skills and attention to detail. Success in this role is marked by the seamless integration of label control processes that ensure patient safety, meet regulatory standards, and effectively support production timelines.

Company Analysis:

Bristol Myers Squibb is a prominent player in the biopharma industry, particularly known for its innovative approaches in areas such as oncology and immunology. The company is driven by a mission to transform patients’ lives through science, which underscores their commitment to health equity and impactful patient outcomes. Within this context, the role of QA CTO Label Specialist is not just a function of quality assurance; it's deeply integrated into a larger vision of delivering therapies that make a tangible difference in patients’ lives. The culture at BMS appears to prioritize collaboration, innovation, and a diversity of perspectives, suggesting that flexibility and teamwork will be vital traits for success in this role. As part of a cross-functional team, the QA Label Control Specialist will need to navigate the complexities of the organization while contributing to the shared goals of patient safety and regulatory compliance. The role also reflects a strategic focus on continuous improvement, as candidates will be encouraged to identify and implement efficiencies in label control processes, aligning with the organization's adaptive and innovative methodology towards therapeutic development.

Mock up some interview questions based on the job description.

Absolutely. Here are some mock interview questions that could come up:

Can you describe a time you identified a quality issue in a labeling process and how you resolved it?
Tell me about an experience where you had to communicate complex regulatory requirements to a non-technical team. How did you ensure understanding?
Describe a significant challenge you faced in a GMP-regulated environment. What adjustments did you make to overcome it?
How do you prioritize multiple tasks when faced with tight deadlines in a manufacturing setting?
What approach would you take to ensure compliance while issuing product labels for clinical trials?
How familiar are you with current GMP guidelines, and how have you applied them in your previous roles?
Discuss your experience with electronic document management systems and how they have impacted your work efficiency.
Imagine you are tasked with training a new team member on the label issuance process. What key topics would you cover?
If you received conflicting information from two departments regarding label specifications, how would you handle the situation?
What interests you most about working with Bristol Myers Squibb, particularly in the context of patient care?
Given the company’s focus on innovation, how do you envision contributing to the continuous improvement of quality processes?
How does your experience align with BMS's mission to deliver the right medicine to the right patient?
What unique perspectives do you believe you can bring to the team at Bristol Myers Squibb?
What specific skills from your background do you see as most beneficial to the QA Label Control team?
In your opinion, what are the most pressing challenges facing the biopharmaceutical industry in quality assurance today?

Job Details

Overview Company

QA Label Specialist

$36/h-$38.46/h

Bristol Myers Squibb

6 days ago

Highlight

OnsiteContractor1+ yearMid

Summary

Bristol Myers Squibb is seeking a QA CTO Label Specialist to join their team in Summit, NJ. The role involves supporting site Label Control activities in accordance with Client policies, standards, procedures, and Global cGMPs.

About the Role

As a Quality Assurance Label Control Specialist, you will be responsible for performing in-process and drug product label printing activities, ensuring accurate and timely issuance of labels for manufacturing and packaging labeling activities. You will support the establishment, maintenance, and continuous improvement of the clinical and commercial label control process, procedures, and responsibilities. Your duties include coordinating with production teams, training internal personnel, writing and updating SOPs, supporting new drug product launches, and providing support during inspections and audits.

About You

Required:

Bachelor's Degree in Science (Biology, Chemistry, etc).
Minimum of 1 year of relevant labeling experience in a cGMP/FDA regulated environment.
Strong communication and customer service skills.
1+ years of experience in the Biopharma.
1+ years of quality experience.
1+ years of labeling experience.
3+ years with MS Office 365.

Preferred:

Crystal reports and BarTender experience.
Some document management experience.

Benefits

401(k)
Commuter benefits
Comprehensive, ACA-compliant health coverage
Dental, vision, Short- and Long-Term disability for eligible employees
Referral bonus program
Unpaid leave and paid sick leave as required by law

Bristol Myers Squibb

At Bristol Myers Squibb, we work every day to transform patients’ lives through science. That work inspires some of the most interesting, meaningful, and life-changing careers you’ll experience. Join us and pursue innovative ideas alongside some of the brightest minds in biopharma, collaborating with a team rich in diversity of experiences, and perspectives. We have built a sustainable pipeline of potential therapies and are leveraging translational medicine and data analytics to understand how we can deliver the right medicine to the right patient, at the right time, to achieve the best outcome.

Whether in a scientific, business or supporting function, a career at BMS means you’ll be inspired every day to grow and thrive through opportunities that are uncommon in scale and scope. Here, you’ll be on the cutting edge of powerful innovation in oncology, hematology, immunology, cardiovascular disease, and fibrosis, with colleagues united in the mission to help patients.

Through the Bristol Myers Squibb Foundation, we also promote health equity and seek to improve health outcomes of populations disproportionately affected by serious diseases and conditions. Our mission is to give new hope to help patients prevail over serious disease – it drives everything we do.

Review our Social Media Community Guidelines at: https://www.bms.com/social-media-community-guidelines.html

Summit, NJ