| Technical Writer at Lexington, Massachusetts, USA |
| Email: [email protected] |
|
From: Vikrama, Valiantiq [email protected] Reply to: [email protected] Role: Technical Writer-VALIDATION & Quality Location: Lexington, MA (ONSITE) Type: Contract Rate is $60/hr. on C2C **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 Thanks & Regards, Vikrama Rao Recruitment Executive- ValiantIQ Inc. "Searching Best Minds Searching Best Minds" Email: [email protected] P. 18032918038 F. (302) 482-3672 Disclaimer: If you are not interested in receiving our e-mails then please reply with a "REMOVE" in the subject line for automatic removal. And mention all the e-mail addresses to be removed with any e-mail addresses, which might be diverting the e-mails to you. We are sorry for the inconvenience. Keywords: Massachusetts Technical Writer [email protected] |
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| 07:49 PM 12-Mar-25 |