Sr. Specialist Deviations & Technical Writing, Drug Product

Job Summary
Responsible for supporting GMP manufacturing operations through high-quality technical documentation, deviation investigation ownership, and cross-functional operational support for clinical and/or commercial drug product manufacturing.

This role is responsible for authoring, reviewing, and managing deviations, CAPAs, technical reports, SOPs, batch record updates, and manufacturing documentation to ensure compliance with cGMP regulations, ALCOA+ principles, and internal quality standards.

The individual will partner closely with Manufacturing, Quality Assurance, MS&T, Engineering, Validation, and Supply Chain teams to support timely investigation closure, process improvements, and manufacturing readiness.

The Candidate acts as a technical resource for manufacturing documentation and quality systems by independently leading deviation investigations, performing root cause analysis, driving corrective and preventive actions, and ensuring clear, concise, and inspection-ready technical writing. This role also supports continuous improvement initiatives, operational excellence programs, and quality culture development across the manufacturing organization.

Location
Norwood, Massachusetts

Job Type
Contract

Salary
$65 - 70 per hour

Work Hours
9 to 5

Education
Bachelors

Responsibilities

Follow all relevant GMP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.

Practice and promote safe work habits and adhere to safety procedures and guidelines.

Execute tasks precisely as defined in internal procedures, Standard Operating Procedures (SOPs), and work instructions.

Follow Good Documentation Practices (GDP) and Data Integrity (ALCOA+) requirements to ensure documentation accuracy, completeness, and inspection readiness.

Author, revise, review, and manage manufacturing deviations, investigations, CAPAs, technical reports, and quality event documentation.

Lead deviation investigations utilizing root cause analysis tools including fishbone analysis, 5-Why methodology, and risk assessments.

Partner cross-functionally with Manufacturing, QA, MS&T, Engineering, Validation, and Supply Chain to gather investigation data and drive timely closure of quality records.

Support batch record review activities and identify documentation discrepancies, procedural gaps, and process improvements.

Author and revise SOPs, work instructions, batch production records, protocols, and technical documentation to support manufacturing operations.

Support implementation and effectiveness checks for CAPAs and continuous improvement initiatives.

Ensure deviations and technical documents are written in a clear, concise, technically accurate, and compliant manner suitable for regulatory inspection.

Track investigation metrics and support efforts to reduce deviation recurrence and improve closure timelines.

Support audit and inspection readiness activities by providing documentation support and responding to quality system inquiries.

Participate in operational excellence initiatives focused on process simplification, documentation standardization, and right-first-time execution.

Provide on-the-floor support for investigations, fact-finding activities, troubleshooting, and manufacturing assessments.

Utilize manufacturing and quality systems as required including, but not limited to, Veeva, SAP, Syncade, DeltaV, LIMS, CMMS, and Microsoft Office applications.

Support training initiatives related to deviation writing, documentation practices, and GMP compliance expectations.

Qualifications

Education: Bachelor's or Master's Degree in Engineering, Life Sciences, Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, or related technical discipline.

Experience: Sr. Specialist typically 5-8 years of experience in pharmaceutical, biotechnology, or medical device manufacturing within a GMP-regulated environment.

Experience: Specialist typically 3-5 years of relevant GMP experience in deviation investigations, technical writing, manufacturing support, or quality systems.

Preferred Qualifications

Experience authoring and managing deviations, CAPAs, change controls, and GMP technical documentation.

Strong understanding of GMP regulations, GDP, ALCOA+, and quality systems.

Experience supporting aseptic processing, solid oral dose, biologics, or sterile drug product manufacturing preferred.

Familiarity with electronic quality management systems (eQMS) such as Veeva, TrackWise, or similar platforms.

Experience with root cause analysis methodologies and risk management tools.

Demonstrated technical writing and editing proficiency.

Skills
Biology, Chemistry, Laboratory Information Management Systems (LIMS), SOP Development, Good Manufacturing Practices (GMP), Corrective and Preventive Actions (CAPA), Good Documentation Practices (GDP)

Equal Opportunity Employer
Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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