Quality Control Scientist I – Biologics Analytical Research & Development

Company Description

AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

AbbVie’s Biologics CMC Analytical Research and Development Group in South San Francisco is seeking a highly motivated Scientist I to join our Quality Control team. The Quality Control team is responsible for a wide range of Quality Control GxP activities, including document management, change management, coordination of outsourced release and stability testing, CoAs, shelf-life evaluation, and coordination of the exception/quality event process. In this role, your responsibilities will include GxP document preparation, processing, and management, data verification, and tracking of timelines and deliverables for release of GMP drug substance and drug product batches. You will be responsible for ensuring compliance with documentation standards, assist scientific and quality control staff with formatting of documents and completing impact assessments for document revisions. You will also provide support for additional quality control related organizational and administrative activities within the Biologics Analytical Research and Development Group.

Responsibilities:

Act as a subject matter expert for GxP quality system document management activities including: document formatting, document processing in the electronic document management system, document categorization/numbering nomenclature, and approval facilitation.

Coordinate closely with document authors, owners, stakeholders and approvers in South San Francisco and other AbbVie sites to initiate and complete document workflows within target timelines.

Collaborate with external third-party GMP labs to obtain and archive TPL documents (including test methods, protocols, and reports) in AbbVie’s electronic document management system.

Prepare and/or assist in preparation of Quality Control documents, including certificates of analysis, method validation reports, reference standard qualification reports, release & stability protocols, and stability reports.

May initiate and coordinate processing of change records in collaboration with Technical and Quality SMEs and stakeholders.

May gather and compile data from multiple source records to enable evaluation.

Organize & manage inventory of analytical development retain sample library.

Ensure compliance with SOPs, standards, and requirements.

Provide support during internal and external audits and inspections

Perform data verification for quality documents and regulatory submissions.

Qualifications

Required: Bachelor’s Degree or equivalent education with typically 5 years of experience, or Master’s Degree or equivalent education with typically 2 years of experience.

General understanding of analytical methods typically employed for release and stability testing of protein therapeutics (monoclonal antibodies and antibody drug conjugates). Prior hands-on experience in a biopharmaceutical quality control lab and/or analytical development lab is a plus.

Knowledge and hands-on experience with document management in the biopharmaceutical industry, including GxP electronic document management systems, is a plus.

Strong knowledge of GxP compliance requirements.

Advanced word processing knowledge and experience with Microsoft Office products

High attention to detail and proven critical thinking skills.

Must have a proactive approach, take initiative, and independently follow through with responsibilities.

Well-developed data and time organization/management skills.

Effective interpersonal, collaboration and communication skills for facilitating collaborations with customers and stakeholders, including scientists, quality control staff, and quality assurance partners.

Must have ability to maintain a high degree of productivity in a dynamic, fast-paced, cross-functional environment.

Must be adaptable and flexible in the face of evolving priorities and timelines.

Effective and timely communications on issues and solutions; both within the team and to the customers and colleagues outside the team.

This position is an on-site role. To be successful, candidates must enjoy and thrive in an on-site, highly collaborative environment with daily face-to-face cross-functional interactions between scientists and colleagues.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

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The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

This job is eligible to participate in our short-term incentive programs. ​

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Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

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AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html