Specialist, Documentation

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.

Requirements

• 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:
• 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.
• 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

Benefits

Additional Information

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.

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