We have a great opportunity for a person who wants to expand their technical writing skills as a Temporary Technical Writer in our MSAT Group in beautiful Portsmouth.
Building upon an already keen eye for precise and timely editing skills, the Technical Writer not only accurately and concisely edits cGMP documents while maintaining a busy document schedule but also begins to broaden their responsibilities within the Technical Writing Group, taking a more independent role. Technical Writers hone their interdepartmental management skills using resources to address comments from internal and external customers as well as regulatory agencies. Stemming from a developing understanding of documentation and manufacturing processes, Technical Writers produce excellence within documents knowing that these documents not only affect the ease of operations within the building but patient safety, drug quality, and business reputation.
What we need you to have:
- Edit documents: Review and template documents with accurate, clear, and explicit description and justifications including not only component-related documents (buffers and medias) but either documents concerning early cell development or documents concerning cell quality and purification.
- Begin to develop proficiency in either upstream or downstream processes
- Create new cGMP documents with assistance from within the department
- Adhere to established departmental practices and protocols
- Manage document comments: Answer and translate questions into the reviewed document to meet regulatory, internal, and external requirements with the aid of document
- Manage global DCFs: Perform initial review for scope, attain sign-offs and justifications, set up review meetings, etc.
- Maintain and review schedules/campaigns: Notify associated departments of deadlines and keep documents within their scheduled timeframe; begin building a deep understanding of how scheduling works; communicating to group and appropriate departments concerning schedules
- Degree in life sciences preferred
- Several years of biotech or pharmaceutical manufacturing industry experience
- Demonstrated document editing and proofreading experience
- Adept at researching
- Basic knowledge of cGMP and manufacturing process knowledge
- Comprehend how CAPAs (corrective actions/preventative actions) and change controls must be incorporated into a document
- Demonstrated proficiency in Microsoft Office Suite; particularly Word, Excel, and Project
- Strong written and oral communication skills
- Initiative to identify and address potential problems
- Highly organized with effective time management (ensuring completion of work tasks)
- Strong attention to detail.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
Lonza. The place to Go, Stay and Grow.