Company Description

AbbVie's 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 people's 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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

The Senior Quality Control Analyst is responsible for conducting the cell-based potency assays(CBPA) of biologics for release and stability of both commercial and late-stage biologics under current good manufacture practice(cGMP). He/She will prepare all documentation associated with the cGMP testing and independently or in a team setting execute protocols in support of manufacture of AbbVie’s biologics product.

The position is responsible for cGMP compliance of the quality control CBPA laboratory, ensuring that all cell Based Potency Assays testing is performed according to the FDA, foreign MOH and AbbVie requirements.

Responsibilities:

1. Perform cGMP testing in support of the manufacture of Abbvie’s biologics products.
2. Generate, compile, and evaluate data for technical reports to support commercial and clinical supplies.
3. Review and approve raw data and laboratory logbooks/worksheets.
4. Perform cell culture and cell banking.
5. Manage critical reagents and supplies.
6. Write quality systems records including laboratory investigations, change controls, non-conformances.
7. Support regulatory inspections where needed.
8. Support new methods validation.
9. Perform and execute activities supporting CBPA lab such as equipment validation, equipment preventive maintenance.
10. Generate and update SOPs.

AbbVie is a regulated company and the incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA.

Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.

Qualifications

Qualifications:

• MS in Chemistry/Biochemistry/Cell Biology or a related Biological Science field with 3+ years of relevant industrial experience or BS in Chemistry/Biochemistry/Cell Biology or a related Biological Science field with 5+ years of relevant industrial experience.
• Proficiency in TrackWise quality system, Microsoft Project, and Excel.
• Experience in a GMP regulated environment.
• Experience in bioassays, Chemi-ECL ELISA preferred.
• Experience with aseptic cell culture and cell banking preferred.

Additional Information

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

• ​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 Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

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

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