Drug Product Investigator
Together, Let’s Make A Difference.
At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.
Every team member, from manufacturing and quality programs to development and facilities services are a critical component to this effort. At our US location, our focused expertise and capabilities makes us one of the industry’s top leaders for large molecule manufacturing and aseptic drug product fill in vials and syringes.
We believe our people are our greatest asset and we are committed to providing our employees with an environment that supports personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come.
Do you enjoy working in a dynamic, inspiring team with an amazing culture? If you do, then Ajinomoto Bio-Pharma Services is the place for you.
We are currently seeking a Drug Product Investigator who investigates and writes out-of-specifications, deviations, preventive actions, change controls and other related cGMP documents under moderate supervision. The Drug Product Investigator 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.
Responsibilities:
- 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.
- Authors and revises compliance, change controls and other technical documentation.
- 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.
- Regular and reliable attendance on a full time basis [or in accordance with posted schedule].
- Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- Embodies Aji Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture.
Requirements:
- Bachelor’s degree in Life Sciences discipline or equivalent required.
- Minimum of two to four (2-4) years of 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.
We provide a Total Rewards package designed to make life better – both at work and at home.
- Annual Bonus Opportunities for All Employees
- 15 Days Starting PTO (Annual Increase) + Sick Time Off + Volunteer Time Off
- Paid Parental Leave
- Annual Company Shutdown in December
- Comprehensive Medical, Dental + Vision
- 401K Company Match + Immediate Vesting
- Backup Daycare and Eldercare
- Monthly Employee Appreciation Events
- Employee Discount Programs
- Tuition Reimbursement
- Casual Dress Code
- Wellness Programs
- Community Outreach Opportunities
If you meet the requirements above, and would like to apply for this position, please visit our website at www.ajibio-pharma.com and click on the "Careers" section. Please be sure to note where you saw our ad posting.
New hires will 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. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.