Quality Associate I - Filling (2nd Shift)

Simtra AeroTech AB; Bloomington (IN); On-site; USD 45,000 - 60,000; Full time

Job summary

Join Simtra AeroTech as a Quality Associate I on the 2nd shift in Bloomington, IN. You will uphold quality standards in manufacturing processes, ensuring compliance with regulatory requirements while contributing to continuous improvement. A supportive team environment awaits where your attention to detail and collaboration skills will make an impact in delivering crucial pharmaceutical products.

Benefits

Medical & Dental Coverage

401(k) Retirement Savings Plan with Company Match

Paid Time Off

Education Assistance Program

Employee Assistance Program

Qualifications

• BS degree in science or 1+ years in GXP regulated industry.
• Knowledge of FDA CFR 210,211 and Good Documentation Practices.
• Intermediate proficiency in MS Office Suite.

Responsibilities

• Ensure compliance with worldwide regulatory agency requirements.
• Perform in-process review of records for cGMP compliance.
• Assist with timely closure of audit observations.

Skills

Regulatory Compliance

Attention to Detail

Team Collaboration

Education

BS degree (preferred science discipline)

AS degree with at least 1 year of Pharmaceutical Quality/Manufacturing experience

No degree with at least 2 years experience in regulated industry

Tools

MS Office Suite (Word, Excel, Outlook)

Enterprise software (i.e., JDE)

Job description

Quality Associate I - Filling (2nd Shift)

Join to apply for the Quality Associate I - Filling (2nd Shift) role at Simtra BioPharma Solutions

Quality Associate I - Filling (2nd Shift)

Join to apply for the Quality Associate I - Filling (2nd Shift) role at Simtra BioPharma Solutions

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 role:

The Quality Associate I is a member of the Quality Assurance Line Operations Team reporting directly to the Quality Associate III. They maintain quality oversight of the manufacturing areas by working closely with manufacturing personnel and performing various checks during manufacturing processes. They also assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Simtra Standard Operating Procedures. This position strives for continuous improvement of processes and contributes to creating an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

This position supports 2nd shift. The hours are from 1430 to 2330, Monday-Friday.

The responsibilities:

• Ensures compliance with all worldwide regulatory agency requirements and company-specific regulations related to quality of product and employee safety
• In-process review of records (batch records and other documents involved in aseptic processing of drug product) to ensure they are complete, accurate, and compliant with current Good Manufacturing Practices (cGMP) requirements
• Reports errors, deficiencies, discrepancies and observations to management and provide direction to halt operations if/when product safety is or may be compromised
• Performs quality functions in classified areas, including production oversight, manufacturing process assessments, and aseptic intervention oversight
• Works in collaboration with management teams to prepare for internal and external audits and assists with timely closure of audit observations and corrective and preventative action responses (CAPAs)
• Initiates and authors nonconformance reports (NCRs) and CAPAs
• Conducts bi-annual inspections of classified areas in preparation for facility shutdown periods
• Initiates standard operating procedure (SOP) revisions as needed to support continuous improvement
• Ensures that SOPs are current and effective, and that staff performs routine tasks according to SOP through direct observation
  
  
  
  

Desirable qualifications:

• BS degree (preferred science discipline), or AS degree with at least 1 year of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience, or no degree with at least 2 years Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience
• Working knowledge of FDA CFR 210,211 and other applicable regulations, and Good Documentation Practices (GDP) required
• Intermediate (or higher) proficiency in MS Office Suite (Word, Excel, and Outlook)
• Ability to use and understand enterprise software (i.e., JDE)
  
  

Physical / Safety Requirements:

• Must wear appropriate PPE as required for various manufacturing areas
• Must be able to gown qualify for Grade A/B areas
• Duties may require overtime work, including nights and weekends
• Position requires standing for long hours, but may require sitting for periods of time
  
  

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.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://simtra.com/privacy-policy/

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Industries

  Food and Beverage Services

Referrals increase your chances of interviewing at Simtra BioPharma Solutions by 2x

Get notified about new Quality Associate jobs in Bloomington, IN.

Quality Associate I - Filling (weekend first shift)

Quality Associate I - Filling (weekend third shift)

Quality Associate I - Filling (weekend second shift)

Quality Assurance I - Line Ops (1st Shift)

Quality Assurance I - Filling (1st Shift)

Quality Associate III - Filling (weekend 2nd shift)

Quality Assurance Specialist, Supply Chain

Scientist, Quality Control (Microbiology) Days

Scientist, Quality Control (Microbiology) Days

Quality Associate III - Filling (Weekend 3rd Shift)

Sr. Sterility Assurance Validation Technician (1st shift)

Operator II, Form / Fill - Weekend Days (Multiple Roles)

Supervisor, Quality Control (PM -2nd Shift)

Supervisor, Quality Control (PM -2nd Shift)

Lead, Filling - Weekday PM - 6PM - 6:30AM; Monday - Wednesday and every other Thursday

Equipment Lead, Form / Fill (Weekday AM)

RCS Senior Associate - Bloomington Hospital

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.