Simtra BioPharma Solutions
Quality Analyst I - 3rd shift
Simtra BioPharma Solutions, Bloomington, Indiana, United States, 47401
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. Our focus is on quality and continuous improvement; we hold ourselves to the highest regulatory standards.
While our primary focus is cGMP manufacturing, we also offer support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. We help clients scale, innovate and bring life‑changing medicines to patients worldwide.
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 Analyst I Batch Release is a member of the Quality Assurance Team (QA) reporting directly to the Quality Supervisor, Batch Release. He or she is responsible for compiling all documentation required for batch manufacturing, including printing of controlled forms from Veeva for each Manufacturing batch produced in their building, generating additional controlled forms needed during the batch manufacturing process, as well as management of the process sign‑out and sign‑in of batch records from the Documentation Center. This role will also assist employees with correction resolution and handle the executed batch record documentation while going through the correction process. Secondary responsibilities may include batch record review, support section review, non‑batch related documentation review, controlled form reconciliation and audit trail review. He or she provides customer service to internal customers and communicates effectively with all levels of the organization.
The responsibilities:
Perform final batch record review
Reconcile discrepancies with documentation and/or electronic systems as appropriate.
Compile documentation packets for batch manufacturing, including printing of controlled forms and other serialized or controlled documentation that is not part of the effective manufacturing batch record.
As needed during operations, generate additional batch documents for batches in progress, such as supplemental batch record sections, controlled forms, and documents of other types.
Manage the process of sign‑out and sign‑in of batch records.
Manage the process of correction resolution, assisting personnel with controlled access to executed records requiring documentation corrections.
Facilitate an environment of teamwork and communication between Quality Assurance, Production and other support functions to ensure on‑time Quality review of batch records in order to achieve internal targets and contractual commitments for batch release.
Participate in continuous improvement projects to improve department operations, increase efficiency, solve problems, generate cost savings, improve quality, and increase employee and customer satisfaction.
Qualifications:
Bachelor’s degree in a science discipline or non‑science discipline with at least three years of Pharmaceutical Quality or Manufacturing experience.
Demonstrated understanding of quality assurance in an FDA‑regulated environment and aseptic processing operations.
Effective organizational, technical and problem solving skills.
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
Must wear appropriate personal protective equipment as applicable.
Duties may require overtime work, including nights and weekends.
Use of hands and fingers to manipulate office equipment is required.
Position requires sitting for long hours, but may involve walking or standing for periods of time.
In return, you’ll be eligible for
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
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.
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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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. Our focus is on quality and continuous improvement; we hold ourselves to the highest regulatory standards.
While our primary focus is cGMP manufacturing, we also offer support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. We help clients scale, innovate and bring life‑changing medicines to patients worldwide.
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 Analyst I Batch Release is a member of the Quality Assurance Team (QA) reporting directly to the Quality Supervisor, Batch Release. He or she is responsible for compiling all documentation required for batch manufacturing, including printing of controlled forms from Veeva for each Manufacturing batch produced in their building, generating additional controlled forms needed during the batch manufacturing process, as well as management of the process sign‑out and sign‑in of batch records from the Documentation Center. This role will also assist employees with correction resolution and handle the executed batch record documentation while going through the correction process. Secondary responsibilities may include batch record review, support section review, non‑batch related documentation review, controlled form reconciliation and audit trail review. He or she provides customer service to internal customers and communicates effectively with all levels of the organization.
The responsibilities:
Perform final batch record review
Reconcile discrepancies with documentation and/or electronic systems as appropriate.
Compile documentation packets for batch manufacturing, including printing of controlled forms and other serialized or controlled documentation that is not part of the effective manufacturing batch record.
As needed during operations, generate additional batch documents for batches in progress, such as supplemental batch record sections, controlled forms, and documents of other types.
Manage the process of sign‑out and sign‑in of batch records.
Manage the process of correction resolution, assisting personnel with controlled access to executed records requiring documentation corrections.
Facilitate an environment of teamwork and communication between Quality Assurance, Production and other support functions to ensure on‑time Quality review of batch records in order to achieve internal targets and contractual commitments for batch release.
Participate in continuous improvement projects to improve department operations, increase efficiency, solve problems, generate cost savings, improve quality, and increase employee and customer satisfaction.
Qualifications:
Bachelor’s degree in a science discipline or non‑science discipline with at least three years of Pharmaceutical Quality or Manufacturing experience.
Demonstrated understanding of quality assurance in an FDA‑regulated environment and aseptic processing operations.
Effective organizational, technical and problem solving skills.
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
Must wear appropriate personal protective equipment as applicable.
Duties may require overtime work, including nights and weekends.
Use of hands and fingers to manipulate office equipment is required.
Position requires sitting for long hours, but may involve walking or standing for periods of time.
In return, you’ll be eligible for
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
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.
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.
#J-18808-Ljbffr