QA Specialist

The Specialist, Quality Assurance is responsible for QA batch record review and disposition assuring that bulk and finished products batch record documentation complies with Abbvie policies, regulatory requirements and current Good Manufacturing Practices. The function ensures the plant products meet specifications and quality requirements. This will require interaction with other Quality Assurance, Production, Engineering, IS and Administration personnel. The batch record review encompasses manufactured batch records, investigation of deviations, exceptions and nonconformance reports.

Responsibilities

• Audit API, Bulk and/or finished Drug Product electronic and manual (paper) batch records to assure compliance with applicable GMPs, policies, procedures and guidelines.
• Evaluate potential discrepancies detected in batch records and determine the need for a corrective action. Approve MES exceptions related to production support.
• Track/trend batch record discrepancies per procedural requirements and work with other departments to evaluate the discrepancies to establish necessary actions to reduce errors.
• Give timely disposition to manufactured products in the SAP system based upon result of testing and compliance with Regulatory Agency requirements. Prepare Certificate of Analysis, Certificates of Compliance for API and/or finished Drug Product.
• Enter and verify batch information into the lot restriction management system. Assemble the batch record review package and label per the approved retention procedures.
• Support the annual product quality review process.
• Prepare reports related to Right the First Time, Release Cycle Time, Regulatory Audit requests and Product Quality Review. Revise procedures as required.
• Coordinate and participate in plant weekly meetings for Shop Floor Control to discuss batch record status including discrepancies and/or issues that may impact batch release.
• Demonstrates accountability and responsibility of EHS performance and compliance.
• Conform to EHS management system requirements and compliance obligations, promote continuous improvement, and consider EH&S aspects during the design and change process. Comply with all EHS procedures and policies including incident reporting, use of PPE, waste management and disposal, and any other program applicable according to the position duties.

 

Qualifications

• Bachelor’s Degree in Science preferably in Biology, Chemistry, Biotechnology, Engineering.
• Two (2) years of experience in Quality regulations and standards affecting pharmaceutical, chemical, biological or medical devices (i.e. Quality Systems, FDA regulations, etc.)
• Knowledge and experience in manufacturing of pharmaceutical or biotechnology products is needed.
• At least one (1) year of experience working in highly computerized Operations environments. Knowledge and experience in SAP, LIMS, MES and biotechnology manufacturing process is necessary.
• Incumbent must have excellent problem solving, analytical and communication and interpersonal skills. Excellent oral and written communication skills in English and Spanish are required.
• For biologics, experience in aseptic processing is preferred.
• Availability to work second and third shifts, including weekends and holidays.

​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. ​

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 and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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