Top Skills: - 2+ years of Document Control & Reporting Experience, - Veeva experience preferred - Technical troubleshooting - Self motivated, independent, great communication - Experience working cross-functionally
Position Summary: The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Cell Therapy Above-site organization, including the document approvals, document change control process, periodic review and system reporting.
Duties/Responsibilities: Primary responsibilities include: • Managing an electronic document system for the Cell Therapy Above-Site which includes reviewing and approving document change requests, troubleshooting and releasing documents to an effective state. • May write and revise document control procedures including participating in the development and roll-out of document control tools. • Follow Policies, SOPs, and work instructions to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests. • Assist with cross-training of Document Control personnel and customers to ensure adherence with procedures. • Execute the process and procedures for identifying, collecting, distributing and filing the controlled documents for the site. • Generate document management system reports for Quality Council metric reporting. • Support internal and external audits and regulatory inspections if required. Assist with document retrieval /organization support during regulatory inspections. • Provide communication as to the status of Quality Systems deliverables to customers, management, and stakeholders. • Some technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principles Position Reports to Jenna Walker – Associate Director, QA Training & Document Control Education: Bachelor’s degree or equivalent
Experience Basic Qualifications: • Minimum of 1 year of relevant document control experience in a cGMP/FDA regulated environment. • Strong communication and customer service skills. • Some technical writing skill set including the ability to critically review documents while effectively inputting and expressing Quality principles. • Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System) • Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement. • Able to prioritize, manage time well, multi-task, and troubleshoot effectively. • Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables. • Possess project management skills. • Experience interacting with FDA or other regulatory agencies strongly preferred. • Strong knowledge of cGMPs and domestic regulatory requirements. • Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.). • Must complete tasks independently, notify manager of decisions outside of established processes and the ability to build an internal network.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. At SPECTRAFORCE , we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $31.12/daily.
