Technical Writing Specialist (GMP, CAPA)

Infotree Global Solutions; New Albany (OH); On-site; USD 85,081 - 106,352; Full time

Job summary

A biotechnology firm in New Albany, OH is seeking a Technical Writing Specialist. The ideal candidate requires a strong background in GMP compliance and experience with the Veeva document management system. Key responsibilities include developing technical content for manufacturing and collaborating across departments for efficient documentation processes. This is a mid-senior level contract position.

Qualifications

• 2+ years of experience in analytical testing.
• Experience with small molecule/peptide analysis.
• Hands-on experience in GMP environments.

Responsibilities

• Develop protocols for Manufacturing.
• Generate Quality System records for minor deviations.
• Support continuous process improvement projects.

Skills

Familiar with Veeva document & quality management system

Prior experience with deviations, RCA methodology, CAPA & EV

Strong analytical skills & cross-functional communication

GMP compliance knowledge

Education

Doctorate degree or Master’s degree with 2 years of experience

Bachelor’s degree and 4 years of experience

High school diploma / GED and 10 years of experience

Job description

Technical Writing Specialist (GMP, CAPA)

Technical Writing Specialist (GMP, CAPA)

3 days ago Be among the first 25 applicants

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Fully Onsite - occasional flexibility to WFH - standard working hours

Ideal candidate: B.S. 2+ YOE would be ideal, previous Veeva experience, and prior deviation and CAPA experience.

As the candidate for this largely laboratory-based position, you will be responsible for driving cutting-edge analytical support and technology development impacting process and product development teams. You will work cross-functionally and across Process Development sites as you use analytical science to help drive efficient development and scalable understanding of processes and products. * Min 2 years' experience performing analytical testing. Preferred Qualifications * Master degree in Analytical Chemistry, Physical or Pharmaceutical or Life Sciences or Engineering related discipline. * Strong theoretical understanding, research in, and hands-on experience in small molecule/peptide analysis in support of process development/scale up activities and formulation development in GMP and non-GMP environments * Experience with a broad array of chromatographic and spectroscopic techniques. * Demonstrate independence and ability to produce quality results under minimal direction * Generate complete, accurate, and concise documentation using electronic systems and laboratory notebook * High energy individual who can multi-task and handle a fast-pace, dynamic work environment * Operate specialized laboratory equipment and instrumentation * Perform general laboratory housekeeping activities * Complete training on assigned tasks * Comply with safety guidelines and site specific procedures which include but is not limited to, the maintenance of training records, laboratory documentation, written procedures, building monitoring systems and laboratory log books

Basic Qualifications

Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience

Top 3 Must Have Skill Sets:

- Familiar with Veeva document & quality management system

- Prior experience with deviations, RCA methodology, CAPA & EV

- Strong analytical skills & cross-functional communication

- GMP compliance knowledge

Day to Day Responsibilities:

• Develop protocols for Manufacturing to support change controls, deviations & troubleshooting investigations with provision from relevant SMEs.

• Generate, own, and provide subject matter expertise to Quality System records as minor deviations, CAPA and change control records.

• Develop, review, and update technical content including but not limited to standard operating procedures, work instructions, risk assessments, protocols & reports for 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 manufacturing team and other cross functional departments regarding documentation changes in an effective and timely manner.

• Collaborate with multiple departments to support new/revise training documentation for manufacturing staff.

• Support process owners and participate in continuous process improvement and / or troubleshooting projects.

• Support manufacturing team in reducing document turnaround times.

• Ensure documentation related actions are completed on time and current schedule is maintained, accurate, and up to date.

• 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Science

• Industries

  Staffing and Recruiting and Biotechnology Research

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