Technical Writer

DESCRIPTION
Create new or revise existing content for SOPs, equipment validation and regulatory submissions with a high degree of quality in accordance with cGMP requirements and corporate guidelines;
Complete gap assessments between Corporate Standards and Site SOPs;
Review, edit and proofread materials written by others as applicable;
Analyze technical literature available, write descriptive copy, and verify documentation;
Review and revise existing documentation to assure it remains current;
May perform other duties such as: Controlled document archival (scanning, filing, etc), Issuance of controlled documents, Miscellaneous administrative tasks as needed.

SKILLS:

Pharmaceutical Manufacturing experience required.
Experience in authoring documents as part of manufacturing, processing, testing, holding and distribution of pharmaceutical or biological products.

EDUCATION
Experience in a Quality Control environment;
Knowledge of GMP and/or ISO standards;
Experience in biotech and/or pharmaceutical manufacturing environment an asset;
Minimum 2 to 5 years related experience in technical writing;
GxP Industry experience preferred;
Knowledge of GxP GLP, GMP, or GCP and 21 CFR Part 11 Regulations;

MUST HAVE AT LEAST 2 YEARS RELATED EXPERIENCE:
Pharmaceutical Manufacturing experience preferred

MOST CRITICAL SKILLS:
Documentation Experience; GXP GLP, GCP, GMP.

QUALIFICATIONS:
Detail oriented with the ability to learn new concepts and apply them quickly;
Good command of MS Office Suite (Word, Excel, PowerPoint, Outlook);
Exceptional written and verbal English communication skills;
Strong working knowledge of editing, proofreading, spelling, grammar, and punctuation;
Ability to effectively communicate with all levels of management and all lines of business;
Superb organizational and time management skills and attention to detail;
Ability to work independently with minimal level of supervision.