Science and Compliance Specialist, Weekend PM

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Medical & Dental Coverage

Flexible Spending Accounts

Life and AD&D Insurance

401(k) Retirement Savings Plan with H%

Job summary

Simtra BioPharma Solutions is seeking a Science and Compliance Specialist to serve as an operations SME, guiding aseptic practices, drafting SOPs, and supporting production through troubleshooting and CAPA execution. This role leads investigations for deviations in a cGMP environment, ensuring accurate records and effective regulatory compliance.

You will collaborate with engineers and QA, manage multiple investigations, and participate in audits while driving safety, quality, and process

Qualifications

• Bachelor's degree in science or technical field; aseptic pharma experience preferred.
• Experience documenting deviations and investigations in a cGMP environment.
• GMP knowledge and regulatory guidelines familiarity.
• Excellent documentation and problem-solving abilities.
• Strong communication and leadership skills.
• Proficiency with enterprise software systems (Veeva).

Responsibilities

• Lead and execute investigations for deviations, define scope, apply problem‑solving, and document results per cGMP.
• Determine Define/Measure/Analyze elements of investigations using appropriate tools.
• Investigate root causes and document results.
• Maintain Investigation records throughout lifecycle.
• Collaborate on CAPA plans and verify CAPA effectiveness.
• Manage multiple investigations with deadlines and accuracy.
• Represent operations during audits and inspections with clear findings.
• Analyze operational data to identify trends and improve efficiency.
• Partner with Process Engineers to drive process improvements.
• Serve as an operations SME on aseptic practices and equipment.
• Draft, revise, and approve SOPs and controlled documents.

Skills

GMP knowledge

Technical writing

Regulatory knowledge

FDA regulations

Veeva

Microsoft Office

Leadership

Problem solving

Communication

Documentation & records

Education

BS degree in science/technical field

Tools

Veeva

Job description

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 Science and Compliance Specialist serves as an operations SME, providing technical guidance on aseptic practices and equipment, drafting and revising SOPs and controlled documents, and supporting production teams through troubleshooting, process optimization, and documentation accuracy. The position also leads and executes end to end investigations for deviations in an aseptic pharmaceutical manufacturing environment, applying structured problem‑solving methods to identify root causes, maintain accurate cGMP compliant records, and drive effective CAPA implementation. It requires managing multiple investigations simultaneously and supporting audits by clearly communicating findings.

Schedule: Friday-Sunday 7:00pm-7:30am

The responsibilities:

• Lead and execute investigations for deviations, including defining scope, applying structured problem‑solving methods, and documenting results in compliance with cGMP standards.
• Determine the Define/Measure/Analyze (problem-solving technique) elements of the investigation by utilizing investigation tools
• Investigate the root cause(s) of the issue and document the investigation results
• Ensure the Investigation record is maintained with current and accurate information throughout its lifecycle
• Collaborate with Action Owners to create effective Corrective and Preventive Action (CAPA) plans and support verification of CAPA effectiveness
• Manage multiple investigations simultaneously, ensuring timely progression and compliance with deadlines
• Represent operations during audits and inspections by clearly explaining investigation scope, rationale, findings, and supporting data
• Review and analyze operational data to identify trends, recurring issues, and opportunities to reduce downtime, increase yield, and improve operator efficiency
• Partner with Process Engineers and Operational Excellence teams to champion improvements that enhance safety, quality, efficiency, and overall process performance
• Serve as an operations subject matter expert (SME), providing technical guidance on process performance, aseptic practices, and equipment operation
• Draft, revise, and approve Standard Operating Procedures (SOPs) and other controlled documents to ensure accuracy, clarity, and compliance with regulatory expectations

Required qualifications:

• BS degree, preferably in a science or technical area or equivalent aseptic pharmaceutical manufacturing experience
• 2+ years technical writing experience, preferably in pharmaceutical industry
• Must have knowledge of GMPs and worldwide regulatory agency guidelines.
• Knowledge of applicable CAPA procedures, specifications, regulations and standards
• Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook) intermediate proficiency
• Goal-setting, prioritize, organization, attention to detail, and time management skills
• Critical & creative thinking and problem-solving skills
• Ability to use logic and scientific principles to reach conclusions when presented with ambiguous data
• Strong oral and written communication skills
• Ability to demonstrate strong leadership skills
• Knowledge of FDA regulations and application of Good Manufacturing Practices (GMP)
• Ability to utilize enterprise software systems (Veeva)

Physical / safety requirements:

• Duties will require overtime work, including nights and weekends on occasion
• Ability to gown in C/D gowning area

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
  • 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
  • Short and Long-Term Disability Insurance
  • 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 12/31/26

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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