Sr. Manufacturing Investigator II

Why join Ajinomoto Bio-Pharma? 

Our mission is to help improve the health of humankind.

We are a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan, and India providing comprehensive development, cGMP manufacturing, and aseptic fill finish services. We pride ourselves in offering a unique environment in which the work we do every day plays a crucial role in society.

We hope to inspire employees to come to work engaged and ready to give their all. This allows Ajinomoto Bio-Pharma to meet the commitments it makes to partners, patients and employees.

Total Rewards package designed to make your life better:

We offer health benefits, annual performance bonus, generous paid time off, paid parental leave, matching 401k contributions (immediate vesting), tuition reimbursement, employee discount program and much more!

Your next career move:

We are currently seeking a Sr. Manufacturing Investigator II who investigates and writes out-of-specifications, deviations, preventive actions, change controls and other related cGMP documents.  The position leads complex and semi-complex investigations and drives resolution of issues and potential problems related to Manufacturing and Inspection.  The Investigator writes and edits standard operating procedures, change controls and other related cGMP documents.  The role reviews, approves and revises of procedures, documents, specifications and forms.  The position also works with multiple departments and cGMP disciplines, such as manufacturing operations, quality control, microbiology, facilities and quality assurance.

Responsibilities:

• Initiates and/or supports complex investigations and resolution of issues / potential problems related to manufacturing.
• Coordinates and supports interdisciplinary working teams with recommendations, advice and action plans for complex investigations, change controls, gap analyses and risk assessments.
• Authors and revises compliance, change controls and other technical documentation.
• Manages specific components of 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 advanced-level support to internal and client audits as needed.
• Actively participates in discussions with clients regarding complex investigations.
• 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 or equivalent experience required.
• Minimum of six (6) years of relevant experience in documentation, cGMP manufacturing, microbiology, quality assurance, or equivalent.
• Minimum of three (3) to five (5) years of experience in pharmaceutical cGMP environment required.
• Previous experience with investigations is required.
• Previous experience writing technical documentation (SOP’s, preventative actions, deviations, reports) is required.
• Has advanced-level understanding of equipment, systems and technologies that enable issues to be translated using accurate documentation.
• Emphasis on aseptic processing and compliance required.
• Must have a solution based attitude.
• Aseptic gowning experience and mechanical aptitude are required.
• Detail oriented with advanced-level English writing skills.
• Advanced-level verbal communication skills.
• Ability to work autonomously, within prescribed guidelines, or as a team member.
• Must be highly proficient with Microsoft Word and Excel.

 

The anticipated hourly range for candidates who will work in California is $34.61 - $45.43.

 

The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the job, type and length of experience within the industry, education, etc. Ajinomoto Bio-Pharma Services is a multi-state employer and this salary range may not re