Overview
Senior Quality Assurance Consultant Jobs in Pennsylvania, United States at Black Diamond Networks
Title: Senior Quality Assurance Consultant
Company: Black Diamond Networks
Location: Pennsylvania, United States
PA: QA Doc Consultant (237050)
Summary
The QA Associate will be responsible for supporting and fostering quality assurance (QA) requirements and activities related to cGXP (primarily GMP but also including Good Laboratory Practice and Good Distribution Practice) in accordance with ICH and FDA regulations and guidelines. This position will also be responsible for quality and regulatory compliance and help assure all systems, processes and their outcomes comply with applicable international and national standards, regulations and guidelines. The primary function of the department is to build, monitor and sustain a robust and effective quality system that delivers reliable, high – quality products that meet all customer and regulatory agency requirements and expectations.
Duties And Responsibilities
Compile Lot Documentation pdfs (including bookmarking combined pdfs)
Upload Manufacturing and Quality Documents into Veeva eDMS System
Support backlog (“bulk”) of manufacturing documents in the Veeva Quality Management System (QMS)
Perform data entry and document uploading into Veeva
Rename and organize documents using established naming conventions
Upload finalized documents into the Veeva system and ensure proper filing
Ensure documents meet quality and compliance standards
Work independently and efficiently to complete tasks
Supporting day to day activities as necessary
Perform other duties as assigned
Upload manufacturing documents into Veeva – Initial Backlog Reduction:
Wakix
Zynerba
EPX-100
NG1
Including documents related to raw materials, Key intermediates, API, Drug Product, Packaging, Labeling, validation protocols and reports, technical reports, etc.
Upload manufacturing documents into Veeva – Maintenance
Assist with Veeva reports for Wakix Annual Product Quality Review
Other: supporting day to day activities as necessary
Training time to get up to speed on the tasks
Qualifications
Bachelor of Science in Quality, Regulatory Affairs, Pharmacy, Chemistry or Biology preferred
3+ years’ experience in pharmaceutical operations preferred
Previous exposure to functional areas of quality assurance
Experience working with electronic quality systems such as Veeva is strongly preferred
High ethical & quality standards and lives them through actions and communication
Demonstrated ability to function independently with minimal guidance
Strong computer (especially Adobe), organizational, and attention-to-detail skills required
Strong verbal and written communication skills
Must think critically and creatively, and have strong organizational and planning skills
About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.
Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
