Job Title: Technical Writing Associate Duration: 02 Years 100% Remote
This is a 100% remote role as the candidate will be supporting teams globally. No preference on time zone.
**This is a very GMP compliance driven role and environment. We need a candidate who will be able to read the SOP's and follow them in a very detail oriented manner.
Summary: Owns and Manages Change Control Records. Owns and Manages Deviations, and Lead Root Cause Analysis. Develops, writes, edits, and formats materials such as Standard Operating Procedures, Business Practices, forms, checklists, technical manuals, installation guides, user manuals, and related technical and business process documentation. When creating, updating and enhancing the documentation, adhere to format, content and style guidelines, giving consideration to usability and ensuring accuracy, consistency and quality. Maintain data accuracy and perform data analysis for Management reviews of the quality system on a periodic basis. Additionally, this position will be required to administer the processing of documents via the established Document Processing Review process. May require communication through a variety of media (e.g., CD, intranet, on-line training, etc.); Skills: ; MS Office expertise; previous technical writing experience; regulated environment experience; document version control experience; excellent communication/writing skills
Responsibilities • Own and manage change control records • Own and manage minor and major deviation records and lead root cause analysis sessions • Own and manage CAPA and CAPA EV records, ensuring that they are implemented as intended. • Maintain data accuracy and perform data analysis for Management reviews of the quality system on a periodic basis. Incidental travel might be required.
Authority • Ability to apply risk-based approach, making decisions and escalating issues appropriately
Outputs • Contribute continuously improving the level of GDP compliance in Global Distribution Supply Chain.
Competencies • Effective communication skills at multiple levels, areas and countries • Ability to apply risk-based approach, making decisions and escalating issues appropriately • Analytical and evidence-based approach to problems. • Ability to see the connection between issues, to identify common factors and bring the correct stakeholders together. • Pro-active in proposing solutions and driving tasks to completion • Works autonomously, respecting deadlines • Works with a high degree of discipline and attention to detail
Qualifications • Minimum Requirements • Bachelor’s degree or equivalent in Life Sciences + 2 years’ experience in GMP / GDP compliance • In the absence of a Life Sciences degree, 4+ years’ experience in GMP / GDP compliance • Sound knowledge of Quality Assurance principles, Good Manufacturing Practice and Good Distribution Practice. • Fluency in English , Dutch-preferable • Strong word processing, database and spreadsheet application skills and experience in Quality Management Software systems (e.g. TrackWise, EDMQ, etc) • Preferred Requirements • Experience in audit / inspection support • Technical writing skills
CPRA: Notice to California Applicants: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
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: $29.00/hr.
