Associate, Product Development Quality

Purpose:

This role is primarily responsible for supporting AbbVies pipeline by supporting batch 
disposition activities and ensuring high-quality 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 ensuring 
schedules are maintained and material is readily available.

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

Significant Work Activities:

- Work in a clean room environment

Qualifications :

• 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.

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 ofthis posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic locationand 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. 

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 anybonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys soleand 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time