QA Document Control Specialist (Tech Writer) - Full-time / Part-time

Position: Technical Writer (Documentation Specialist) R&D

Responsibilities:

• Develop design control documentation, including Design and Development Plans, Development Reports, Test Method and Process Validation Protocols, FMEAs
• Develop and update Manufacturing procedures, QC procedures, and other documents from a Device Master Record (DMR)
• Manage document change control
• Regularly interact with subject matter experts and attend project team meetings
• Manage documentation review and approval: Proactively solicit and rapidly incorporate feedback from other functions (QA, RA, R&D, MFG, etc).
• Maintain integrity of documents to comply with and be incorporated into the company's quality procedures. High quality, well formatted, clear documentation following GDP (good documentation practices) is mandatory.
• Work with minimal supervision and manage time effectively
• Deliver under tight deadlines
• Identify and communicate risks to project deadlines in advance
• Adapt to changes in project priorities
• Any other duties as required for the role

Requirements:

• B.S. degree in a life science (biomedical) or quality field.
• A minimum of 3 years of experience supporting IVD products, including writing Design Control documentation and DMR documentation.
• Experience in Molecular Diagnostics preferred
• Advanced knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook, etc.).
• Strong experience in Design Control, ISO 13485, and 21 CFR Part 820 Quality Systems Regulation.
• Quick learner, thorough understanding of presented technical/scientific content.
• Ability to write clearly, concisely, accurately, and quickly under tight deadlines.
• Keen attention to detail and high regard for quality.
• Experience working in a self-driven, performance/results oriented, fast paced matrixed environment.
• Willingness to take on new challenges.
• Able to adapt to changing needs caused by time, budget, or other constraints.
• Excellent problem solving skills, including issue resolution.
• Must be highly collaborative; Have the ability to work within a diverse team and contribute to a supportive, positive work environment both within the team and in the greater community

About Aerotek:

Our people are everything. As a Best of Staffing® Client and Talent leader, Aerotek® Inc. has distinguished itself as a leader in recruiting and staffing services, by having a deep understanding of the intersection of talent and business. As a strategic partner to more than 17,000 clients and 300,000 contract employees every year, Aerotek's people-focused approach yields competitive advantages for its clients and rewarding careers for its contract employees. Headquartered in Hanover, Md., Aerotek operates a network of over 230 non-franchised offices with more than 6,000 internal employees dedicated to serving our customers. Aerotek is an operating company of Allegis Group, a global talent solutions provider. To learn more, visit .

Aerotek is acting as an Employment Agency in relation to this vacancy.