Senior Associate Product Development Quality

Purpose:

This role is primarily responsible for supporting AbbVies pipeline by supporting batch
disposition activities and ensuring highquality clinical supplies that are compliant with global
regulatory requirements and standards are delivered to patients. This is achieved by effectively
partnering with the business ensuring risks are mitigated appropriately and supporting efficient
review of clinical supply batches to support continued uninterrupted access to clinical supplies.
The successful candidate will be able to manage multiple tasks and adjust priorities based on
supply needs. This position requires the ability to positively interact with multiple functional
areas quickly and effectively resolve batch record documentation related issues independently
ensuring schedules are maintained and material is readily available.

Responsibilities:
List up to 10 responsibilities of the job including information regarding scope and accountability.

• Review and approve batch records and release batches or analytical records.
• Write/ review/ approve processes/procedures and related documents.
• Lead/assist in the preparation and management of audits conducted by regulatory agencies customers and R&D GxP Compliance.
• Provide quality approvals in the materials management system as defined by procedures.
• Write review and/or approve exception documents and product complaints (as applicable) corrective actions/preventive actions (CA/PA) and ensure they meet timeliness requirements.
• Review/approve clinical documentation and specifications as applicable.
• Actively lead/participate on assigned project team(s) to support the product development. process by using expertise to anticipate/resolve quality issues.
• Generate analyze and report quality metrics to management.
• Lead/participate with support groups in developing/prior

This is a hybrid role onsite in Lake County IL. 

Qualifications :

• Bachelors (typically in life sciences (biology chemistry or engineering) and/or equivalent experience.
• 4 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 of complex activities.
• Proven organizational team leadership and negotiation skills to handle conflicting 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 complex problems through effective use of technical and interpersonal skills.

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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Work :

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