Senior QC Analyst Onsite

The Senior Quality Control Analyst or scientist II is responsible for conducting the cellbased potency assays(CBPA) of biologics for release and stability of both commercial and latestage 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 AbbVies 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.

• Perform cGMP testing in support of the manufacture of Abbvies biologics products.
• Generate compile and evaluate data for technical reports to support commercial and clinical supplies.
• Review and approve raw data and laboratory logbooks/worksheets.
• Perform cell culture and cell banking.
• Manage critical reagents and supplies.
• Write quality systems records including laboratory investigations change controls nonconformances.
• Support regulatory inspections where needed.
• Support new methods validation.
• Perform and execute activities supporting CBPA lab such as equipment validation equipment preventive maintenance.
• 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 SarbanesOxley 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 :

• 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. 
• Experience with the application of aseptic cell culture cell banking and 96well format bioassay techniques for potency determination of proteins and their degradation and modification products.
• Skill in the use of and programming multiple equipment for bioassays such as Synergy2 Neo2 MSD imager Luminex Plate reader. Experience in the application of liquid handlers in cellbased assay automation and related software for data analysis is a plus.
• Skills in addition to bioassays including West blot qPCR qELISA and antibody conjugation (HRP and biotin) are preferred.
• Ability for technical troubleshooting in particular root cause analysis and CAPA development/implementation is a must.
• Proficiency in TrackWise quality system Microsoft Project and Excel. 
• Experience in working in cGMP regulated environment is required.
• A solid understanding of methods and procedures related to the production and characterization of biopharmaceuticals in a regulated environment is expected.
• Well developed written and oral communication skills. Motivate to work in a team environment.
• Consistently deliver on commitments and respond to department needs in a timely and courteous manner.
• Demonstrated knowledge of the use of a continuous improvement methodology in a lab testing environment.

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 shortterm incentive programs. 

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 Companys 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 AbbVies 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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