Drug Product Technical Writer – Investigations
Let’s Make Things Happen!
Ajinomoto Althea, Inc. is a fully integrated contract development and manufacturing organization providing clinical drug process development and manufacturing services to global biotechnology and pharmaceutical companies.
Althea is a leading expert in aseptic filling of drug product in vials and syringes, and our focused expertise and capabilities make us one of the industry’s top leaders for cGMP microbial fermentation of recombinant proteins and plasmid DNA. In conjunction with these manufacturing operations, Althea offers comprehensive development services including: upstream and downstream process development, complex formulations, lyophilization cycle, analytical development, product release and ICH-compliant stability testing.
Now is an exciting time to join Althea. We have talented people working together to help our clients advance their innovative product pipelines. We believe that people are our greatest asset and we are committed to providing our employees with an environment that fosters personal and professional growth.
Our work atmosphere is fast paced, stimulating and customer focused. Employees take pride in knowing our efforts are helping countless patients for years to come.
Althea is currently seeking an experienced Drug Product Technical Writer – Investigations. This position is largely responsible for translating information gathered form investigations into written technical documents. This position also investigates and writes out-of-specifications, deviations, preventive actions, change controls and other related cGMP documents under moderate supervision. The position supports moderately complex investigations and resolution of issues / potential problems related to Drug Product Manufacturing and Inspection. The position writes and edits standard operating procedures, change controls and other related cGMP documents. In addition the role may coordinate the review, approval and revision of procedures, documents, specifications and forms. The Investigator will work with multiple departments and cGMP disciplines, such as manufacturing operations, quality control, microbiology, facilities and quality assurance.
- Authors and revises compliance, change controls and other technical documentation.
- Initiates and/or supports moderately complex investigations and resolution of issues / potential problems related to Drug Product Manufacturing.
- Coordinates and supports interdisciplinary working teams with recommendations, advice and action plans for moderately complex investigations, change controls, gap analyses and risk assessments.
- Manages specific components of moderately large scale deviations.
- Tracks and trends documentation and data as specified.
- Maintains a GLP/cGMP environment and follows Standard Operating Procedures (SOPs).
- Adjusts responsibilities and activities to meet client and internal expectations.
- Follows up on open documents to ensure close out of investigations to enable product release in a timely manner.
- Provides support to internal and client audits as needed.
- Embodies Althea’s cultural values and aligns daily actions with department goals and company culture.
- Bachelor’s degree in Life Sciences or equivalent experience required.
- Minimum of two to four (2-4) years of relevant experience in documentation, cGMP manufacturing, microbiology, quality assurance, or equivalent.
- Minimum of one (1) year of experience in pharmaceutical cGMP environment required.
- Has good understanding of equipment, systems and technologies that enable issues to be translated to create accurate documentation.
- Previous experience with investigations is preferred.
- Previous experience writing technical documentation (SOP’s, preventative actions, deviations, reports) preferred.
- Emphasis on aseptic processing and compliance preferred.
- Must have a solution based attitude. Aseptic gowning experience and mechanical aptitude are a plus.
- Strong listening and interpretive skills to successfully translate events into clearly written documents.
- Detail oriented with very strong English writing skills.
- Strong verbal communication skills.
- Ability to work independently, within prescribed guidelines, or as a team member.
- Must be highly proficient with Microsoft Word and Excel.
If you meet the requirements above, and would like to apply for this position, please visit our website at www.altheacmo.com and click on the "Careers" section. Please be sure to note where you saw our ad posting.
Successful candidate must pass a background check and drug screen as a condition of employment.
We are an EOE dedicated to a diverse work force and Drug Free work environment.
Qualified M/F/D/V candidates are encouraged to apply.