Validation & Technical Writer — GMP/Data Integrity

Mindlance; Andover (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

A national recruiting company is seeking a candidate to support QC Analytical and Microbiology departments in ensuring data integrity of QC instruments. This involves conducting gap assessments, collaborating with subject matter experts to propose gap closure recommendations, and managing documentation. Candidates should possess a BS degree in a scientific discipline and have 3-5 years of experience in a relevant GMP role. Strong interpersonal and technical writing skills are necessary for this role.

Qualifications

• 3-5 years of experience in a relevant GMP role.
• Strong interpersonal skills for collaboration.
• Familiarity with QC instrumentation in biopharmaceutical field is preferred.

Responsibilities

• Support QC Analytical and Microbiology departments.
• Conduct gap assessments on QC instruments.
• Facilitate gap closure recommendations with SMEs.
• Author Corrective & Preventive Action plans (CAPAs).
• Manage gap assessment reports through approval workflows.

Skills

Validation lifecycle knowledge

Data integrity knowledge

Technical writing skills

CAPA and change control process knowledge

Interpersonal communication skills

Detail-oriented approach

Education

BS in Scientific discipline

Job description

A national recruiting company is seeking a candidate to support QC Analytical and Microbiology departments in ensuring data integrity of QC instruments. This involves conducting gap assessments, collaborating with subject matter experts to propose gap closure recommendations, and managing documentation. Candidates should possess a BS degree in a scientific discipline and have 3-5 years of experience in a relevant GMP role. Strong interpersonal and technical writing skills are necessary for this role.