Manufacturing Technical Writer

Category:

Life Science

Employment Type:

Contract To Hire

Reference:

BH-381311-1

QA Technical Writer

Noblesville, IN - ONSITE

6 month W2 contract to hire
Pay rate: $30-35/hr - Depending on Education and Experience

Responsibilities:

• Utilize technical writing strategies to ensure content of documentation is clear, concise, and complete.
• Author and revise technical documentation including facility and equipment SOPs, batch records, specifications, and training documents.
• Author and manage change controls as necessary to implement new procedures as well as revisions to documentation and SOPs to facilitate launch of new products.
• Participate in process and equipment testing to learn systems being documented.
• Complete deviations, CAPAs, change controls, document revisions and training activities to meet quality system requirements and timelines.
• Coordinate with operations, R&D, and quality representatives to ensure all project documentation requirements are achieved.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
  

• Must be able to communicate clearly in English and have solid communication skills including grammar and composition.
• Demonstrated understanding of GMP / cGMP regulations.
• Skill in communication, written and verbal with the ability to interact with cross-functional teams.
• Proven time management skills and a strong attention to detail.
• Proven ability to manage and coordinate multiple projects in a fast-paced, highly professional environment.
• Ability to work well with others and independently.
• Able to read, understand and follow work instructions in a safe, accurate and timely manner.
• Proficiency in computer skills and experience with Microsoft Word, PowerPoint, and Excel.

• Bachelor Degree or equivalent work experience required.
• 3 or more years of relevant experience required.

• Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.
• Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.
• Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require

• Medical, Dental & Vision Benefits
• 401K Retirement Saving Plan
• Life & Disability Insurance
• Direct Deposit & weekly ePayroll
• Employee Discount Programs
• Referral Bonus Programs