Specialist, Documentation

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Process, edit, verify and custody documents on the documentation system such as: procedures, specifications, test methods, production control records (PCRs) and support documentation systems and SAP. Verify changes are aligned with operating system such as SAP, LIMS, MES/POMS and Delta V.

Responsibilities:

• Verify and receive documents. Notify users of possible changes in documents.
• Process documents in the Documentation System. Add / revise document properties. Establish document effective dates. Approve documents and properties in the document management system and release for distribution.
• Route change request packages for review and approval, monitor responsiveness of approvers and assure appropriate approvals obtained. Communicate with initiator and customer for status updates and if implementation period needs to be negotiated.
• Complete work according to established priorities, policies, practices, and procedures to assure product documentation is delivered on schedule.
• Verify and coordinate changes to synchronize with operational systems, documentation system and ABC plant when documents are shared.
• Execute and/or verify SAP and/or DSP changes.
• Determine and implement problem solving and corrective actions related to department and documentation processing activities.
• Train employees on change control process.
• Prepare/revise manual PCRs to be used in the manufacturing areas. Manage record retention room and coordinate transfer of documents to Iron Mountain supplier.
• Provide assistance to operations in accordance with environmental management, occupational health and safety (EHS) systems and promote continuous improvement. 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: 

• Associate Degree in Business Administration or Natural Sciences preferably, with three (3) years of experience in documentation control.
• High School Degree or GED with five (5) years of experience in documentation control.
• Five (5) years of experience in pharmaceutical industry, preferred.
• Knowledge of computerized procedures system. Knowledge of Good Manufacturing Practices.
• Computer system knowledge in Microsoft Word, Excel and SAP.
• Good verbal and written communication skills in English and Spanish. Ability to work with multiple priorities with minimal supervision. Ability to lead work groups and achieve the effective performance of tasks.

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 atthe time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors includinggeographic 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 aparticular 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