QA Documentation Specialist

The QA Documentation Specialist 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.

Significant Work Activities

• Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required.
• Frequent to continuous computer usage (greater or equal to 50% of the workday) is required.

Qualifications :

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.
• Availability to work weekends overtime and holidays according to business needs.

Additional Information :

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion.  It is AbbVies 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 protected veteran or any other legally protected group status.

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