Quality Analyst Lead- Batch Review
Simtra US LLC, Bloomington, IN, United States
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. 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.
This role
The Quality Batch Release Lead ensures the roles and functions of the Quality Assurance (QA) Batch Release department are performed in accordance with regulatory agency rules and guidelines and Baxter quality procedures. The group performs batch record review and finished product disposition for all GMP batches produced at Baxter. This role provides customer service to internal and external customers, as well as participates in escalated client issue resolution, and leads in the development of customer awareness activities. The supervisor also provides leadership and guidance to direct reports and creates an environment where teamwork, productivity, safety, identity, strength, purity and quality are reflected in the finished product. This position reports to a Quality Manager, QA Documentation Center.
Responsibilities
Perform final batch record review and disposition of batches.
Reconcile discrepancies with documentation and/or electronic systems as appropriate.
Compile documentation packets for batch manufacturing.
As needed during operations, generate additional batch documents for batches in progress. This may include 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 real 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 with 2 years experience in Pharmaceutical Quality or Manufacturing, or Bachelor's degree in a non‑science discipline with 4 years of Pharmaceutical Quality or Manufacturing experience.
Knowledge of aseptic manufacturing processes 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
Must wear appropriate personal protective equipment as applicable.
Duties will 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.
Benefits
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
(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.
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/
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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. 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.
This role
The Quality Batch Release Lead ensures the roles and functions of the Quality Assurance (QA) Batch Release department are performed in accordance with regulatory agency rules and guidelines and Baxter quality procedures. The group performs batch record review and finished product disposition for all GMP batches produced at Baxter. This role provides customer service to internal and external customers, as well as participates in escalated client issue resolution, and leads in the development of customer awareness activities. The supervisor also provides leadership and guidance to direct reports and creates an environment where teamwork, productivity, safety, identity, strength, purity and quality are reflected in the finished product. This position reports to a Quality Manager, QA Documentation Center.
Responsibilities
Perform final batch record review and disposition of batches.
Reconcile discrepancies with documentation and/or electronic systems as appropriate.
Compile documentation packets for batch manufacturing.
As needed during operations, generate additional batch documents for batches in progress. This may include 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 real 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 with 2 years experience in Pharmaceutical Quality or Manufacturing, or Bachelor's degree in a non‑science discipline with 4 years of Pharmaceutical Quality or Manufacturing experience.
Knowledge of aseptic manufacturing processes 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
Must wear appropriate personal protective equipment as applicable.
Duties will 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.
Benefits
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
(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.
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/
#J-18808-Ljbffr