Deviation Investigation Support

propharmagroup; United States; On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Hybrid work option

Job summary

ProPharma Group seeks a deviation writer for a 15-month contract in the United States. You will participate in meetings with site representatives, perform root cause investigations, and manage deviation records through CAPA and approvals.

Requirements include a background in Quality Control Laboratories, strong technical writing, and experience with QMS tools (LabVantage, Veeva QMS). Hybrid work is supported.

Qualifications

• Background in Quality Control Laboratories.
• Experience in root cause investigation and CAPA creation.
• Excellent communication, technical writing and time-management skills to ensure timely and high-quality deviation writing and timely approval.
• Experience with Veeva QMS, MODA and SmartLab would be helpful in ensuring their success in this space.
• Experience in LabVantage is a must.
• #LI-EB3

Responsibilities

• The deviation writers will be involved in meetings with site representatives for deviation events, collaborating with SMEs as needed, and providing deviation investigation support with updates as needed.
• The deviation writers will go through training with the company and be responsible for: completion of training on time, presence and engagement at meetings, clear communication of progress on deviation records, ownership of deviation records through approval including but not limited to the following activities:
• Thorough root cause investigation, including process background, event overview, creation of CAPA(s) and effectiveness checks.
• Set-up deviation review board when applicable.
• Route deviation records for review and approval.

Skills

Quality Control Laboratories

Root cause investigation

CAPA creation

Technical writing

Communication

Time management

Tools

Veeva QMS

MODA

SmartLab

LabVantage

Job description

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.

This will be a 15-month contract, beginning in Q4 2026 through the end Q4 2027.

Responsibilities

• The deviation writers will be involved in meetings with site representatives for deviation events, collaborating with SMEs as needed, and providing deviation investigation support with updates as needed.
• The deviation writers will go through training with the company and be responsible for: completion of training on time, presence and engagement at meetings, clear communication of progress on deviation records, ownership of deviation records through approval including but not limited to the following activities:
• Thorough root cause investigation, including process background, event overview, creation of CAPA(s) and effectiveness checks.
• Set-up deviation review board when applicable.
• Route deviation records for review and approval.

Required Skills and Qualifications

• Background in Quality Control Laboratories.
• Experience in root cause investigation and CAPA creation.
• Excellent communication, technical writing and time-management skills to ensure timely and high-quality deviation writing and timely approval.
• Experience with systems such as Veeva QMS, MODA and SmartLab would be helpful in ensuring their success in this space.
• Experience in LabVantage is a must.
• #LI-EB3

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

Whilst ProPharma supports remote working, we also recognise the value that comes from in-person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.