Associate, Product Development Quality jobs in United States
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AbbVie · 9 hours ago

Associate, Product Development Quality

AbbVie is dedicated to discovering and delivering innovative medicines that address serious health issues. The Associate, Product Development Quality role involves supporting the pipeline by ensuring the delivery of high-quality clinical supplies and managing batch disposition activities while collaborating with various functional areas.

BiotechnologyFinancial ServicesHealth CareMedicalPharmaceuticalVenture Capital
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Review and approve batch records and release batches or analytical records
Write/review/approve exception documents and product complaints (as applicable) corrective actions/preventive actions (CA/PA) and ensure they meet timeliness requirements
Assist in the preparation of audits conducted by regulatory agencies, customers, and GxP Compliance
Provide quality approvals in materials management system as defined by procedures
Write and/or review policies/processes/procedures and related documents
Actively participate on assigned project team(s) to support the product development process and timelines by using expertise to anticipate/resolve quality issues
Generate and report quality metrics to management
Participate with support groups in developing/prioritizing QA activity timelines
Actively monitor the effectiveness of processes and quality of project work with management and propose and execute quality/process improvements
Provide quality oversight on the manufacturing floor, as needed

Qualification

Quality AssurancePharmaceutical ManufacturingGMP ComplianceAnalytical SciencesOrganizational SkillsTeam Negotiation SkillsInterpersonal SkillsCommunication Skills

Required

Bachelors (typically in life sciences (biology, chemistry, or engineering) and/or equivalent experience
2+ years industry experience in Quality Assurance, production, testing of active pharmaceutical ingredients, drug products, drug development or other healthcare related field; less experience considered with advanced degree
Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical sciences, and worldwide -global requirements for GMP (D, EU, US) is preferred
Experience in coordination and planning activities
Demonstrated organizational skills
Interpersonal and team negotiation skills to handle multiple priorities
Effective use of oral and written communication skills to clearly communicate the quality position, and the actions necessary to resolve issues
Ability to identify and resolve quality issues through effective use of technical and interpersonal skills

Preferred

Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical sciences, and worldwide -global requirements for GMP (D, EU, US) is preferred

Benefits

Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Short-term incentive programs

Company

AbbVie is a biopharmaceutical company focused on immunology, oncology, neuroscience, virology, and aesthetics. It is a sub-organization of AbbVie.

H1B Sponsorship

AbbVie has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (273)
2024 (190)
2023 (225)
2022 (284)
2021 (186)
2020 (186)

Funding

Current Stage
Public Company
Total Funding
$15B
2024-02-27Post Ipo Debt· $15B
2023-03-08Post Ipo Equity· $0.25M
2012-12-20IPO

Leadership Team

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Robert Michael
Chairman of the Board and Chief Executive Officer
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Micah Bregman
Vice President, Global Strategy and Pipeline, Allergan Aesthetics
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Company data provided by crunchbase