QA Engineer, Document Control Specialist

Primary Purpose and Overall Objective of the Job:

The QA Engineer – Document Control Specialist is responsible for supporting the Quality Management System at the Philadelphia site by maintaining document controls and assisting with other quality projects at the site. Under the guidance of the Quality Manager the incumbent is responsible for,

Main Accountabilities:

• Maintenance of quality system records including preparation, verification and filing of Quality documentation to ensure that it meets applicable customer, regulatory, and corporate requirements.
• Assist employees in obtaining identification numbering for internal and external documents, and controlled documentation.
• Responsible for initiating, verifying, and maintaining records for non-conformances, deviations, root-cause-investigations and CAPAs.
• Responsible for maintaining Doc. Control KPIs
• Assist with continuous improvement programs/projects to improved compliance to regulatory and industry standards.
• Assist in employee training and maintain employee training records under the QMS.
• Processing and review of document change requests.
• Complete data entry in quality databases for new and modified documents.

Typical Studies-Experience, Skills, and Qualifications:

Studies-Experience:

• • • BA/BS Degree in a life science or related field and a minimum three (3) years of experience in related industry required. Advanced degree with one (1) plus years of experience preferred.

Skills and Qualifications:

• Prior experience with Quality Management Systems procedures and document control preferred. Familiarity/knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (ISO9001, ISO13485, ISO17025) is a plus.
• Experience managing nonconformances, investigation writing experience preferred.
• Computer skills required, should be proficient with Microsoft Office Package (Excel, Word, etc.)
• Competence in the use of Quality Tools and Techniques and knowledge of quality systems (SAP/LIMS/Trackwise) is a plus.
• Excellent interpersonal skills and ability to work with all levels of an organization.
• Ability to work independently and in a team environment.
• Ability to prioritize and balance multiple deadlines in a fast-paced deadline driven environment.

Scope and Resources Accountability, Typical Performance Indicators:

• Scope and Resources Accountability: N/A
• Financial Indicators (revenue, budget, etc.): Site revenue, number and complexity of products, number of product launches per year.
• Key Performance Indicators (KPIs): Conformity with quality standards and procedures, Document revision turnaround times, Customer complaints.
• Key Contacts (internal/external) and Interfaces: Quality Director/Manager, R&D and Ops Department Heads, QC department, General Managers, Site / Subs Managers, other Functional Leaders.

Language(s):

Language A:

English  Fluent