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Job Information

Actalent Quality Assurance, Document Control in Philadelphia, Pennsylvania

Description:

• Manage and maintain controlled documents in Electronic Document Management System (EDMS) with little or no assistance/direction

• Independently review SOP and form content and exercise judgments to provide suggestions to author to ensure alignment with Spark controlled document procedures and best practices

• Assist in the development, administration, and validation of electronic Quality Management Systems (QMS)

• Track controlled documents to ensure reviews and approval are completed within the EDMS

• Coordinate the review, finalization, and archival of Spark policies, procedures, and other controlled documents

• Edit and proofread controlled documents for consistency of document format and adherence to Quality Systems processes and procedures

• Follow GxPs and Spark SOPs and Policies

• Implement and utilize advanced Word processing and automation features of MS Office software

• Lead the implementation of document control process improvements

• Other assigned responsibilities as established by the GMP Quality Lead

Skills:

QA, batch records, SOP, raw materials, documentation, GMP, manufacturing, labeling

Top Skills Details:

QA, batch records, SOP, raw materials, documentation, GMP, manufacturing, labeling

Additional Skills & Qualifications:

• B.A./B.S. in biological sciences, physical sciences or equivalent experience

• 2-5 years of experience in working with documentation in a regulated industry

• Computer literacy required; advanced Microsoft Office skills (Outlook, Word, Excel, PowerPoint)

• Knowledge of GxP Requirements and guidelines.

• Experience with document control activities.

• Experience with Document Control system.

• Requires strong written, oral, interpersonal, and communication skills and English fluency.

• Effective knowledge of maintaining a document and data control system.

• Effective organization and planning skills.

• Demonstrated ability to adapt to frequent changes, delays, or unexpected events.

• Ability to follow established policies, procedures and comply with regulatory requirements related to documentation.

• Demonstrated ability to perform detail-oriented work with a high degree of accuracy and completeness.

Experience Level:

Intermediate Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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