Quality Control Specialist

About this role

Job Description

Position Responsibilities: • We are seeking a Growth and Improvement-minded Data Services Specialist in Quality Control that can help drive our Strategic Operating Priorities.

• Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs

• Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)

• Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape

• Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world

• Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us

  Summary, Focus and Purpose • The QC Data Services Specialist is responsible for stability laboratory data review, plant site release, review of site APR, data trending, and support of Quality Notifications and CAPAs.

• They demonstrate mastery of all data management and documentation programs (GLIMS, MEDS, IPI, SAP, etc.).

• Maintains positive site relations and supports other company divisions and third-party manufacturing and packaging sites.

• Assures compliance with FDA & GMP regulations. 

• Demonstrates the ability to influence a team (including Global Support and Outside Organizations) and is a recognized resource to others.

  Key Functions   Development • Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

• Participate in development of objectives and ensure alignment with site goals

  Laboratory Support • Initiating/leading problem solving to identify short-term and long-term actions to prevent problem reoccurrence, reduce laboratory downtime and increase reliability

• Following standard work for escalation as it relates to safety and quality events

• Timely approval of qualification, change control, procedures and other documents

• Demonstrates a deep understanding of customer needs, requirements, and expectations

• Performs stability and plant site release and study approvals

• Supports GLIMS updates; reviews builds, IPI specification verification

• Review of technical memos and testing protocols

  Information Transfer • Attends departmental and team meetings focused on Stability data review and reporting

• Serves as liaison between NASU teams, Leadership, and External Entities

• Ability to interpret our Company Quality Policies and Guidelines for daily application.

• Participates and/or Directs Tier Meetings

• Promotes teamwork and open discussion of issues.

• Statistical summary analysis for manufacturing site Annual Product Reviews (APR)

Education Requirements: • Bachelor of Science degree, preferably in Chemistry, Biology, or Engineering with ≥ 2 years in a pharmaceutical laboratory setting

Required Experience and Skills: • Prior experience in a pharmaceutical laboratory setting.

• Knowledge and experience with data management and documentation programs (GLIMS, MEDS, IPI, SAP, etc.)

Required Skills: Adaptability, Analytical Instrumentation, Analytical Method Development, Dissolution Testing, Driving Continuous Improvement, GMP Compliance, Karl Fischer Titrations, Laboratory Documentation, Laboratory Safety, Microbiological Analysis, Microbiological Test, Teamwork, Technical Writing, Troubleshooting, Use of Laboratory Equipment Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

The salary range for this role is $87,300.00 - $137,400.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefi

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