Manufacturing Technical Services Representative

Simtra BioPharma Solutions•Bloomington, IN

58d•Onsite

About The Position

The Manufacturing Technical Services Representative is a member of the core client team and interacts directly with clients. The Manufacturing Technical Services Representative is responsible for technical and process improvement aspects of the project. This position is 100% onsite at the Bloomington facility and reports to the Manager, Manufacturing Technical Services.

Requirements

BS degree, preferably in a science-related field
Familiar with quality operating procedures, quality and regulatory requirements pertinent to pharmaceutical, biological and biochemical quality
Strong communication skills, both written and verbal, with the ability to interact with many functions and levels across the organization
Strong organizational skills, attention to detail, and collaboration skills with the ability to meet tight deadlines and manage multiple projects concurrently
Intermediate proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook)
Ability to use enterprise software (i.e., JDE, Trackwise, etc.)
Ability to qualify for Grade C areas
Duties may require overtime work, including nights and weekends
Position may require sitting or standing for long periods of time
Ability to qualify for Grade C areas

Responsibilities

Owner and technical expert of commercial master batch records (MBR) for assigned projects - author, maintain and revise MBRs
Review and release commercial batch records to production for execution
Train manufacturing personnel on new and/or significant changes to MBRs
Investigate Non-Conformance Report (NCR) and determine root cause to assign/own the corrective action(s)
Authors technical studies in support of investigations or process improvements
Own change controls and associated tasks
Approve project related Bill of Materials
Commercial contact for assigned internal and external clients
Manages client project updates and reviews with all levels of management
Participate (with assistance) in Business Review Meetings
Partner with Program Management, Quality Assurance Associates, Quality Control Representative, and Manufacturing Representative to coordinate projects, provide support, align facility representation, and provide consistent quality information
Participate on client calls and on-site visits to discuss projects and issue resolutions
Participate (with assistance) in regulatory, client and internal audits as a product/process Subject Matter Expert (SME) and own the responses for observations
Evaluates non-conformance situations for product impact and responsible for advising if product meets release criteria
Use knowledge of manufacturing systems and equipment to write batch record and perform other duties
Understands the Quality Agreement, Master Batch Record (MBR), Quality Control Master Document (QCMD), Regulatory and Procedural requirements that govern the client/company relationship and product