Tech Services Representative (Weekend Shift, Friday - Monday, 08:30-19:00)

About the role

The Technical Services Floor Support Representative is a member of the Technical Transfer Team (MSAT) that provides onsite processing support to Manufacturing. This position is 100% onsite at the Bloomington facility and reports to the Sr. Manager, Technical Transfer. This role is a full-time weekend position that works Friday to Monday (4 x 10 hrs).

Responsibilities

• Responsible for making and delivering accurate and timely decisions pertaining to projects, questions, and requests
• Escalates issues to impacted departmental manager, project owner, and/or Director as necessary for corrective action implementation
• Pairs with Quality Assurance Associate, Quality Control Representative and Manufacturing Representative to coordinate projects, provide support, align facility representation, and provide consistent information
• Deviation investigation writing with assistance
• Filter troubleshooting and testing, including PUPSIT
• Able to provide expertise in aseptic processing
• Capable of evaluating product impact and responsible for advising if product meets release criteria per regulatory constraints
• Understands the technical requirements of each project
• Understands the Master Batch Record (MBR), Quality Control Master Document (QCMD), Regulatory and Procedural requirements that govern the client/company relationship and product

Requirements

• BS/BA degree, preferably in the science or engineering field, or 4+ years of Pharmaceutical Industry experience with a focus on formulation, filtration, and filling processes in lieu of education
• Knowledge of quality operating procedures, quality and regulatory requirements pertinent to pharmaceutical, biological and biochemical quality
• Knowledge of systems and equipment - including scales, mixing systems and mixing monitoring methods, aseptic formulations, fill volume limit setting, disposable formulation technology, homogeneity testing, control charting, identification and response to trends
• Ability to be a self-starter and work independently on projects and tasks
• Ability to use critical & creative thinking and problem-solving skills
• Ability to write and perform Technical Services Studies (TSS)
• 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
• Intermediate proficiency in Microsoft Office Suite (Word, Excel, Outlook) and MiniTab
• Ability to use and understand enterprise software (i.e., D365, BPLM, Pilgrim, Trackwise, etc.)

Physical / Safety Requirements

• Duties may require overtime work, including nights and weekends
• Position may require sitting or standing for long periods of time in a classified environment
• Ability to qualify for Grades A, B, and C areas

Benefits

• Day One Benefits
• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
• Spouse Life Insurance
• Child Life Insurance
• 401(k) Retirement Savings Plan with Company Match
• Time Off Program
• Paid Holidays
• Paid Time Off
• Paid Parental Leave
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program
• Community and Volunteer Service Program
• Employee Ownership Plan
• Short and Long-Term Disability Insurance
• Voluntary Insurance Benefits
• Vision Coverage
• Accident
• Critical Illness
• Hospital Indemnity Insurance
• Identity Theft Protection
• Legal

Additional Benefits

• Onsite Campus Amenities
• Workout Facility
• Cafeteria
• Credit Union