Job Summary

This position will be responsible for the filing and keeping inventory of Batch Records, Raw Material and Packaging components records and Issuance of CoA (Certificate of ), CoM (Certificate of Manufacturing Compliance Release), CoC Certificate of (Certificate of Compliance Release) with compliance to site Standard Operating Procedures, current Good Manufacturing Practices, and in accordance with the registered product specifications. This position is responsible for updating these compliance release documents when the registered product specifications change. This position is responsible for the inventory management of all batch related documentation that is maintained in the vault on site as well as Iron Mountain. This position is responsible for managing checking out batch documentation for internal and external audits. This position supports all departmental activities as time allows to support the release of product.

Job Details

This position is responsible for the following:

• Responsible for the filing and keeping inventory of Batch Records, Raw Material and Packaging components records.

• Coordinate transfer of documentation to off-site archiving locations.

• Complete and conform to all training requirements for job role, including company-required and job role-specific training.

• Carry out and assist in the on-going training of new and existing personnel, as appropriate.

• Assess and understand events that may not be in accordance with procedures or cGMPs. Make decisions consistent with job.

• Empowered to make Quality decisions.

• Participate and support OPEX initiatives and seek process innovation and continuous process improvement.

• Reviews documents and collaborates with Production to identify defects and manufacturing trends.

• Prepares required documentation, including CoA’s, regarding batch disposition to international sites as required.

• Performing the Quality Assurance Issuance of all batch related documents for manufacturing, production, validation, and quality assurance departments.

• Issue batch records to support manufacturing and Production for the Waco facility ensuring accuracy, compliance, adherence to Data Integrity, and current Good Manufacturing Practices.

• Issue PSO, Clinical Studies, Demonstration, and Validation Batch Records for Production use.

• Perform other duties as assigned to include batch issuance and batch review.

Minimum requirements for this position are:

Essential Knowledge, Skills & Abilities:

• Excellent analytical and problem-solving skills, detail oriented.
• Excellent organizational skills. Ability to manage multiple tasks.
• Working knowledge of Quality Assurance systems, cGMP’s, ISO 13485, CMDRs, and EMEA regulations.
• Detail-oriented and self-motivated
• Excellent hand-eye coordination and manual dexterity.
• Excellent math skills; ability to add, subtract, multiply, and divide.
• Ability to read, comprehend, write, and communicate effectively in English.
• Ability to carry out detailed written or oral instructions.
• Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment.
• Basic user knowledge and understanding of Windows based computer systems such as Microsoft Office, with an ability to learn other computer-based systems.
• Physically able to lift up to 40 lbs.

AbbVie is an equal opportunity employer including disability/vets. 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.