Manufacturing Documentation Specialist Supervisor

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.

 

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The role:

The Manufacturing Documentation Specialist Supervisor oversees a team of individuals responsible for the review of executed documentation for the Manufacturing department with regard to compliance to current Good Manufacturing Practices and Good Documentation Practices. The Documentation Specialists Supervisor assigns tasks to the Documentation Specialist Team and reports on performance metrics.

Its responsibilities:

• Provide guidance, support, direction and leadership through positive interactions with all personnel during daily operations.
• Form partnerships with other business functions (e.g. Quality Assurance, Technical Services, and Finishing) in order to achieve internal targets and contractual commitments for batch release
• Identify and prevent potential non-conformance issues
• Maintain and report applicable documentation review and submission metrics.
• Support department lean initiatives and provide input to improve processes.
• Lead continuous improvement projects to improve department operations, increase efficiency, solve problems, generate cost savings, improve quality, and increase employee and customer satisfaction.
• Manage manufacturing documentation centers, including flow of documents, corrections, final review and submission of records to quality assurance to meet designated timelines.
• Supervise the day-to-day review, scheduling, staffing, material management, compliance, training and auditing activities to meet customer requirements. 

Desirable qualifications:

• High School diploma or GED required
• Bachelor's Degree strongly preferred
• Two years of manufacturing experience preferred.
• Minimum 1 year leadership experience required
• Experience with pharmaceutical regulations preferred, including current Good Manufacturing Practices and current Good Documentation Practices
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include:  JDE, BPLM, Pilgrim, Trackwise, SCADA (or similar) system, etc.)

 Physical / safety requirements:

• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position may require standing or sitting for extended periods of time
• Physical coordination/flexibility to allow gowning for clean room environments
• Must be able to gown qualify for Grade C/D areas.
• Must be able to gown qualify for Grade B areas.

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
• 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 12/31/24

 

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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.
                                                                                                                                                            
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