Must have skills - We are looking for people with MS Word, TrackWise and Veeva Quality Docs experience. Someone with Change Control/Change Management (not batch record review) experience.
Job Summary: The Technical Writer III is responsible for the development, creation, and revision of controlled documentation in accordance with policies and procedures, current GMP, 21CFR820, ISO 13485 and AATB Standards. Establishes partnerships and works with Change Control, Quality Engineer team members, and other cross functional managers/supervisors and development engineers/teams to ensure that controlled documents being revised contain the correct information per process/product specifications.
Education and Experience • University Degree BA/BS, Science, Communications, Engineering, or English (preferred) • Previous experience in pharmaceutical, medical device, or biotech industries. • 3-5 years’ experience in Technical Writing in a GMP or medical device manufacturing environment. • In-depth knowledge of MS Word including use of tables, headers/footers, and review capabilities. • In depth knowledge of EDMS Systems (e.g. Veeva Vault). • Project Management capabilities.
Essential Skills, Experience, and Competencies (includes Licenses, Credentials) • In depth knowledge of document authoring tools, including MS Office Suite. • Demonstrated ability in proofreading and editing. • Ability to multi-task and adjust to shifting priorities. • Strong interpersonal skills including the ability to effectively work and actively communicate with people and cross-functional teams. • Excellent oral and written communication skills as well as strong organizational skills. • Strong analytical skills, with an eagerness to work hard and achieve exemplary results. • Expert grammatical competency and writing skills. • Basic knowledge of FDA, GXP, 21CFR820, ISO 13485 and AATB requirements and industry best practices. Preferred Qualifications: • Previous experience in pharmaceutical, medical device, or biotech industries. • In depth knowledge of MS Word including use of tables, headers/footers, and review capabilities. • In depth knowledge of EDMS System (Veeva Vault). • Project Management capabilities.
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: $63.25/hr.