Technical Writing Specialist

Pay rate: $33.00 - $35.00/hr.

Responsibilities

• Support the manufacturing team and provide technical expertise to regularly draft and revise documents such as Standard Operating Procedures (SOPs), protocols, technical reports, and training material in a GMP regulated environment that supports the manufacturing process.
• Develop, review, and update technical content including but not limited to standard operating procedures, work instructions, risk assessments, protocols, and reports for the manufacturing team.
• Provide technical and clerical support to the manufacturing team in the preparation of documentation, collation of data, and tracking of technical documents.
• Liaise with the manufacturing team and other cross-functional departments regarding documentation changes in an effective and timely manner.
• Collaborate with multiple departments to support new or revised training documentation for manufacturing staff.
• Support process owners and participate in continuous process improvement and/or troubleshooting projects.
• Support the manufacturing team in reducing document turnaround times.
• Ensure documentation-related actions are completed on time and the current schedule is maintained, accurate, and up to date.
• Develop protocols for Manufacturing to support change controls, deviations, and troubleshooting investigations with input from relevant Subject Matter Experts (SMEs).
• Generate, own, and provide subject matter expertise to Quality System records such as minor deviations, CAPA, and change control records.
• Track pending activities required to support change control implementations.
• Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current operating systems.
• Share knowledge with members of the manufacturing team.

Qualifications

Basic Qualifications

• Master's Degree in Science and/or Engineering.
• OR Bachelor's Degree in Science and/or Engineering and 2 years in Manufacturing, Packaging, or Quality experience in pharmaceutical, medical device, or biotechnology companies.
• OR Associate’s Degree in Science and/or Engineering and 5 years in Manufacturing, Packaging, or Quality experience in pharmaceutical, medical device, or biotechnology companies.
• OR High School Diploma / GED and 8 years in Manufacturing, Packaging, or Quality experience in pharmaceutical, medical device, or biotechnology companies.

Preferred Qualifications

• Educational background in Science and/or Engineering.
• Experience working in GMP pharma and/or biotechnology industry.
• Experience in a Good Manufacturing Practices (GMP) environment and demonstrated background in technical writing.
• Experience with device assembly and packaging of final product.
• Ability to translate highly technical information into easily understandable information for manufacturing operators.
• Dynamic skills and usage of photographs, drawings, diagrams, animation, and charts that increase users’ understanding.
• Experience supporting deviations, investigations, CAPAs, and change controls.
• Fact-based problem solver with strong troubleshooting and problem-solving skills.
• Proactive with the ability to prioritize work to meet benchmarks.
• Good documentation and communication skills.

Top 3 Must-Have Skill Sets

• GMP background.
• Prior deviation/investigation ownership.
• Excellent written and oral communication.

Preferred: Bachelor of Science with 2+ years of experience, previous Veeva experience, and prior deviation and CAPA experience.

Pay

The typical base pay for this role across the U.S. is $33.00 - $35.00 per hour. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education, and experience.

Benefits

Full-time employees are eligible to select from different benefits packages. Packages may include:

• Medical, dental, and vision benefits.
• Health savings accounts with qualified medical plan enrollment.
• 10 paid days off, 3 days paid bereavement leave.
• 401(k) plan participation with employer match.
• Life and disability insurance.
• Commuter benefits.
• Dependent care flexible spending account.
• Accident insurance, critical illness insurance, hospital indemnity insurance.
• Accommodations and reimbursement for work travel.
• Discretionary performance or recognition bonus.

Sick leave and mobile phone reimbursement provided based on state or local law.