What are the responsibilities and job description for the Technical Writer (QC and Regulatory documents) - LPTK9276 position at TechData Service Company LLC?
Company: Large Pharmaceutical Company
Title: Technical Writer
Contract Position: 6 months with potential extension
Location: Lexington, MA - on site.
Description:
Primary duties are non-laboratory support of the QC analytical methods functions in method validation and method transfer projects.
Primary activities would generally include but not limited to
Authoring analytical method and support documentation for QC release and stability testing of biologics.
Authoring method validation protocol and reports to support technology transfers.
Creation, review, and revision of comprehensive method validation protocol, reports, , ensuring accuracy and adherence to ICH, FDA, EMA, regulatory standards.
SPECIFIC QC FOCUS AREA
Analytical Methodologies for potency, impurities, content, and identity attributes in biologics (recombinant proteins, antibodies, ADCs, fusion proteins, enzymes, etc.).
(i.e.: cell based assays, residual ProteinA, host cell protein, residual DNA, protein determination)
If possible, proven hands-on testing experience in QC laboratories.
EXPERIENCE REQUIREMENTS
Independent Technical Writing Skills in Quality Control and Regulatory departments (must perform the designated author role, not just the reviewer/approver role).
Expert knowledge in data analysis.
Experience on test methods and method validation for internal teams and external partners.
KEY SKILLS
Skilled in proper laboratory compliance through detailed documentation practices.
Experienced in the use of electronic laboratory notebooks and electronic data storage systems to maintain accurate records.
Strong written, verbal, and interpersonal communication abilities, successful in a team environment
LIMS and Empower software platforms
Must have knowledge of periodic documentation of assay trends, to maintain compliance and improve operational efficiency
Job Posting Start Date: 2025-04-07
Job Posting End Date: 2025-10-07
Business Unit: 3383-Shire HGT Inc
Site: US-MA-Lexington 300
Location: US-MA-Lexington 300
Posting Information
Job Posting Owner: -
Comments
Comments To Supplier: This role is ONSITE!
Salary : $55 - $85
