Manual Inspection Group Leader

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. 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.

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. We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.



Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

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.

This Role

The Manual Inspection Group Leader provides leadership, coaching and communication on an individual and group basis to meet client demand and expectations. The Group Leader contributes to creating an environment where teamwork, productivity, Safety, Identity, Strength, Purity and Quality are reflected in the finished product. This position reports to a Finishing Supervisor.

The Responsibilities

Manual Inspection Operations Monitoring & Execution

• Monitor Manual Inspection performance and update visual controls
• Communicate processt delays to appropriate levels of management as well as subsequent shifts
• Manage and track TOR (Time out of refrigeration) for refrigerated product
• Coordinate material delivery and pick-up with Warehouse and Label Control personnel
• Manage electronic inventory transactions at the time of activity completion
• Coordinate with Technical Services and Engineering to process Technical and Qualification studies, respectively
• Monitor and ensure batch record requirements and applicable SOPs (Standard Operating Procedures) are being followed/executed properly
• Input data into electronic reports
  

Batch Record Review and Completion

• Discover and correct any documentation errors that occur
• Ensure no documentation omissions exist and all activities are documented at the time of performance
• Complete batch record review immediately following batch completion
• Ensure batch record reviews allow achievement of desired first pass quality
• Review batch record and batch record forms for accuracy and completeness; sign for review
• Successfully complete batch record review course and qualification
• Meet with subsequent shift group leader to review critical batch record information and documentation
• Assist with investigations stemming from production deviations or errors
  
  

Talent Development and Coaching

• Develop operators in their respective competencies via coaching and creating opportunities to learn/perform new responsibilities
• Provide verbal and written feedback for individuals with whom you have led or worked with for performance evaluations and individual development
• Communicate client demand, processing instructions and objective to team members
  
  

Set-up/Tear down/Clearance

• Organize and assign responsibilities for area clearances
• Review and confirm comprehension of FSS (Finishing Specification Sheet) for Manual Inspection operators
• Ensure clearance activities meet established turnaround targets
• Allocate appropriate personnel to complete assigned tasks
  
  

Other

• Required to maintain attendance in accordance with the Bloomington Attendance Policy
• Scheduled weekend overtime may be required
• Visual acuity 20/20 with or without corrective vision and ability to pass color blind test
• Ability to successfully pass all Manual Inspection qualifications
• Ensure all safety practices are followed and keep area clean and clear of hazards
  
  

The Work Environment

Controlled pharmaceutical environment including wearing long sleeves, safety toe shoes, gloves and safety glasses. Ability to work in a team environment on a variety of automated and semi-automated packaging lines.

Desirable Qualifications

• High school diploma or GED required
• Minimum 2 years related experience preferred
• Team Oriented
• Problem identification and solving
• Good communication skills
• Good documentation skills, including legible handwriting
• Basic computer and math skills
• Ability to understand and follow standard operating procedures, specifications, and job-specific training materials
• Ability to understand, speak, read and write English
  
  

Physical / Safety Requirements

• Must be able to meet 20/20 corrected vision requirement and pass color blind test
• Must be able to lift, push/pull, and carry up to 35 pounds
• Duties may require overtime work, including weekends
• Use of hands and fingers to manipulate equipment is required
  
  

Additional Requirement(s)

Final candidates for Manual Inspection Group Leader will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.

In return, you’ll be eligible for[1]:

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

[1] Current benefit offerings are in effect through 12/31/25

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

Equal Employment 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.

EEO is the Law

EEO is the law - Poster Supplement

Pay Transparency Policy

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:

https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy