Quality Lab Associate III - QC Compliance Analyst

Simtra US LLC; Bloomington (IN); Presencial; USD 90.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Day One Benefits

401(k) Retirement Savings Plan with 2H

Paid Time Off and holidays

Education Assistance Program

Employee Assistance Program

Descripción de la vacante

Simtra BioPharma Solutions in Bloomington, Indiana seeks a QC Compliance Lead to oversee quality compliance activities within QC, ensuring regulatory adherence and client satisfaction. This role drives audits, continuous improvement, and risk management across the QC function.

The candidate will guide risk-based prioritization, support audit responses, and author SOP revisions, while collaborating with multiple teams to uphold high standards for patient safety and product quality.

Formación

• Bachelor's degree in a physical science.
• Minimum of 5 years of experience in Quality.
• Experience with client/regulatory audits preferred.
• Proficient in Word, Excel, and Outlook; able to use enterprise software (e.g., JDE, BPLM, Pilgrim, Trackwise).

Responsabilidades

• Act as the QC Compliance lead.
• Provide guidance and leadership for QC quality compliance risks.
• Prioritize workloads based on compliance risk.
• Aid in client responses and corrective actions based on client findings.
• Participate in Client and Regulatory audits.
• Authors SOP revisions and CI-related documents.
• Review regulatory changes affecting QC.
• Communicate with QC groups to plan regulatory and client compliance.

Conocimientos

Quality compliance

Audit coordination

Regulatory knowledge

Educación

Bachelor's degree in physical science

Herramientas

JDE

BPLM

Pilgrim

Trackwise

Descripción del empleo

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.

The QC Compliance Lead is responsible for overseeing quality compliance activities within the Quality Control organization, ensuring adherence to regulatory requirements, client expectations, and internal quality standards. This role provides compliance leadership, supports audits and inspections, drives continuous improvement initiatives, and serves as a key partner in managing quality and compliance risks across the QC function.

The responsibilities:

• Acts as the QC Compliance lead
• Provides guidance, support, direction and leadership for any quality compliance risks for the QC group.
• Prioritizes workloads and assigns duties based on compliance risk.
• Aids in client responses and CIs based on client findings
• Participates in Client and Regulatory audits
• Authors SOP revisions and any technical writing documents needed for CI completion
• Performs review of regulatory changes and shifts in focus of regulatory agencies
• Communicate with QC groups to determine plan for regulatory and client compliance

Required qualifications:

• Bachelor's degree in a physical science required
• Minimum of 5 years of experience in Quality
• Previous client/regulatory audit experience preferred.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)

Physical / Safety Requirements:

• The position sometimes requires extended periods of sitting.
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required

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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