Simtra BioPharma Solutions
Manufacturing Technical Services Representative
Bloomington, Indiana, United States · Mid
Sponsorship not specifiedDetected 12 days ago
ExcelProcess ImprovementGMPCommunicationCollaborationOrganizational SkillsMicrosoft Office
About the role
- Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market.
- Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines - which are all directly injected into patients worldwide.
- As such, there is a strong emphasis on quality and continuous improvement at Simtra.
Responsibilities
- Owner and technical expert of commercial master batch records (MBR) for assigned projects - author, maintain and revise 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
- Manages client project updates and reviews with all levels of management
- 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 (with assistance) in regulatory, client and internal audits as a product/process Subject Matter Expert (SME) and own the responses for observations
- 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
- Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
Requirements
- BS degree, preferably in a science-related field
- Strong communication skills, both written and verbal, with the ability to interact with many functions and levels across the organization
- 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
Benefits
- Make it COUNT - We take pride in our day-to-day work, knowing the impact we make - taking on challenges big and small to improve patient health.
- Day One Benefits
- Medical & Dental Coverage
- Flexible Spending Accounts
- Supplemental Life Insurance
- Spouse Life Insurance
- Child Life Insurance
- 401(k) Retirement Savings Plan with Company Match
- Time Off Program
- Paid Parental Leave and more
- Adoption Reimbursement Program
- Education Assistance Program
Company info
- With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
- While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.
Equal opportunity
- Simtra is proud to be an equal opportunity employer.
- Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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This listing is sourced directly from Simtra BioPharma Solutions's careers page and normalized into a canonical job model.