Sr. Supervisor Quality Compliance Job at Baxter (Irvine)

New

Sr. Supervisor Quality Compliance

Location

United States , Irvine

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree in engineering, Science or related field
3+ years of Quality, Manufacturing, Engineering or related field which should include 2+ years of NCR/CAPA experience. 1-2 years of supervisory experience
Experience of coordinating and supporting Document Control, Internal Audit, CAPA and Non-conformance
Thorough knowledge of applicable procedures, specifications, regulations and standards
Strong analytical and problem-solving skills
Ability to manage/supervise a team of employees
Good interpersonal/communication/influencing/negotiation skills
Strong command of problem-solving techniques and ability to coach others in their application
Good project management skills
Must be able to write clearly and informatively, edit work for spelling and grammar, presents numerical data effectively, able to read and interpret written information

Job Responsibility

Oversee the daily operations of a section or department, ensuring product quality, performance, and safety meet regulatory requirements and company standards
Develop, implement, and maintain quality systems procedures to ensure compliance with regulatory requirements and company standards within the section or department
Develop, maintain, and update inspection documentation procedures to ensure compliance with product regulations and company standards
Coordinate site audit-readiness activities, including internal, corporate and external audits and regulatory inspections, to ensure compliance and assess risk within the organization
Coordinate and facilitate site inspections by regulatory agencies and Notified Bodies and serve as the primary point of contact during inspections
Responsibilities include interviewing, hiring, and training employees
planning, assigning, and directing work
appraising performance
rewarding and disciplining employees
address any issues or concerns that may arise

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts

Fulltime

Sr Executive I, Quality Assurance

This is where you make a difference in our patients’ safety. As a member of the ...

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

To take instructions from Supervisor and shift lead to perform the shift activity
To verify the correct raw material, primary packaging material, and Quantities are issued and dispensed as per the approved Batch records
To perform the line clearance activity at various stages of manufacturing and packaging activity as defined in the BMR
To perform routine In process checks, sampling, periodic verification, online documentation as defined in batch records and escalate any nonconformances
To collect In-process samples, finished product samples, and other samples timely submission into QC/micro
To review and verification of electronic records/Audit trails and printout of the equipment’s like autoclave, sterilizer, filter integrity machine
To ensure the respective documents to be destructed as per approved procedure
To ensure the compliance and GDP of logbooks, online documents, records, and other supporting documents
To ensure & provide support to Shift Lead or Supervisor in investigation
To execute the approved Corrective and Preventive Action (CAPA) with in define timeline

Job Responsibility

Play an essential part in our mission of saving and sustaining lives
Ensure product safety and quality throughout the entire product lifecycle
Work collaboratively with all areas of the organization

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

New

Sr Executive I, Quality Assurance

This is where you make a difference in our patients’ safety. As a member of the ...

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

To take instructions from Supervisor and shift lead to perform the shift activity
To verify the correct raw material, primary packaging material, and Quantities are issued and dispensed as per the approved Batch records
To perform the line clearance activity at various stages of manufacturing and packaging activity as defined in the BMR
To perform routine In process checks, sampling, periodic verification, online documentation as defined in batch records and escalate any nonconformances to shift lead and supervisor and ensure appropriate actions (CAPA) in place
To collect In-process samples, finished product samples, and other samples timely submission into QC/micro
To review and verification of electronic records/Audit trails and printout of the equipment’s like autoclave, sterilizer, filter integrity machine and any other equipment’s etc.
To ensure the respective documents to be destructed as per approved procedure
To ensure the compliance and GDP of logbooks, online documents, records, and other supporting documents related to products manufactured in the plant and data integrity is ensured
To ensure & provide support to Shift Lead or Supervisor in investigation, in case of any product complaints or non-conformities or Out of Specification
To execute the approved Corrective and Preventive Action (CAPA) with in define timeline

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Sr Executive I, Quality Assurance

This is where you make a difference in our patients’ safety. As a member of the ...

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

To take instructions from Supervisor and shift lead to perform the shift activity
To verify the correct raw material, primary packaging material, and Quantities are issued and dispensed as per the approved Batch records
To perform the line clearance activity at various stages of manufacturing and packaging activity as defined in the BMR
To perform routine In process checks, sampling, periodic verification, online documentation as defined in batch records and escalate any nonconformances to shift lead and supervisor and ensure appropriate actions (CAPA) in place
To collect In-process samples, finished product samples, and other samples timely submission into QC/micro
To review and verification of electronic records/Audit trails and printout of the equipment’s like autoclave, sterilizer, filter integrity machine and any other equipment’s etc
To ensure the respective documents to be destructed as per approved procedure
To ensure the compliance and GDP of logbooks, online documents, records, and other supporting documents related to products manufactured in the plant and data integrity is ensured
To ensure & provide support to Shift Lead or Supervisor in investigation, in case of any product complaints or non-conformities or Out of Specification
To execute the approved Corrective and Preventive Action (CAPA) with in define timeline

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Sr Executive I, Quality Assurance

This is where you make a difference in our patients’ safety. As a member of the ...

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

To take instructions from supervisor or QA Head to manage Document Control activity
To ensure the implementation and maintenance of current Good Manufacturing Practice (cGMP) standards
To review and verify that any GDP issues have been addressed
To issue and close Logbooks to the respective plant, as per request of respective department from Controlled Forms System (CFS)
To archive executed Logbooks, Standard Formats, Batch Manufacturing Record in the record room and submit to central record room
To issue completed records from record room and ensure its storage, achieve & timely disposition
To verify BMR (Batch Manufacturing Record) and BPR (Batch Packing Record) for each new product introduced for manufacturing, whether for regulatory filings (exhibit batches) or for commercial distribution (approved products)
To review BMR based on initial product transfer input received from Quality or F&D / TTD as per requirement
To Prepare / review BMRs and BPRs by integrating product specifications from Technical Package (TP) and processing parameters from site
To verify BMR (Batch Manufacturing Record) and BPR (Batch Packing Record) in TcU, based on approved BMRs and BPRs production planning schedule and after generating a batch number assignment

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Sr Executive I, Quality Assurance

This is where you make a difference in our patients’ safety. As a member of the ...

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

To take instructions from supervisor or QA Head to manage Document Control activity
To ensure the implementation and maintenance of current Good Manufacturing Practice (cGMP) standards
To review and verify that any GDP issues have been addressed
To issue and close Logbooks to the respective plant, as per request of respective department from Controlled Forms System (CFS)
To archive executed Logbooks, Standard Formats, Batch Manufacturing Record in the record room and submit to central record room
To issue completed records from record room and ensure its storage, achieve & timely disposition
To verify BMR (Batch Manufacturing Record) and BPR (Batch Packing Record) for each new product introduced for manufacturing, whether for regulatory filings (exhibit batches) or for commercial distribution (approved products)
To review BMR based on initial product transfer input received from Quality or F&D / TTD as per requirement
To Prepare / review BMRs and BPRs by integrating product specifications from Technical Package (TP) and processing parameters from site
To verify BMR (Batch Manufacturing Record) and BPR (Batch Packing Record) in TcU, based on approved BMRs and BPRs production planning schedule and after generating a batch number assignment

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Sr Executive I, Quality Assurance

This is where you make a difference in our patients’ safety. As a member of the ...

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

To take instructions from supervisor or QA Head to manage Document Control activity
To ensure the implementation and maintenance of current Good Manufacturing Practice (cGMP) standards
To review and verify that any GDP issues have been addressed
To issue and close Logbooks to the respective plant, as per request of respective department from Controlled Forms System (CFS)
To archive executed Logbooks, Standard Formats, Batch Manufacturing Record in the record room and submit to central record room
To issue completed records from record room and ensure its storage, achieve & timely disposition
To verify BMR (Batch Manufacturing Record) and BPR (Batch Packing Record) for each new product introduced for manufacturing, whether for regulatory filings (exhibit batches) or for commercial distribution (approved products)
To review BMR based on initial product transfer input received from Quality or F&D / TTD as per requirement
To Prepare / review BMRs and BPRs by integrating product specifications from Technical Package (TP) and processing parameters from site
To verify BMR (Batch Manufacturing Record) and BPR (Batch Packing Record) in TcU, based on approved BMRs and BPRs production planning schedule and after generating a batch number assignment

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

New

Sr Executive I, Quality Assurance

Aquí es donde usted marca la diferencia en la seguridad de nuestros pacientes. C...

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

To take instructions from Supervisor and shift lead to perform the shift activity
To verify the correct raw material, primary packaging material, and Quantities are issued and dispensed as per the approved Batch records
To perform the line clearance activity at various stages of manufacturing and packaging activity as defined in the BMR
To perform routine In process checks, sampling, periodic verification, online documentation as defined in batch records and escalate any nonconformances to shift lead and supervisor and ensure appropriate actions (CAPA) in place
To collect In-process samples, finished product samples, and other samples timely submission into QC/micro
To review and verification of electronic records/Audit trails and printout of the equipment's like autoclave, sterilizer, filter integrity machine and any other equipment's etc
To ensure the respective documents to be destructed as per approved procedure
To ensure the compliance and GDP of logbooks, online documents, records, and other supporting documents related to products manufactured in the plant and data integrity is ensured
To ensure & provide support to Shift Lead or Supervisor in investigation, in case of any product complaints or non-conformities or Out of Specification
To execute the approved Corrective and Preventive Action (CAPA) with in define timeline

Job Responsibility

To take instructions from Supervisor and shift lead to perform the shift activity
To verify the correct raw material, primary packaging material, and Quantities are issued and dispensed as per the approved Batch records
To perform the line clearance activity at various stages of manufacturing and packaging activity as defined in the BMR
To perform routine In process checks, sampling, periodic verification, online documentation as defined in batch records and escalate any nonconformances to shift lead and supervisor and ensure appropriate actions (CAPA) in place
To collect In-process samples, finished product samples, and other samples timely submission into QC/micro
To review and verification of electronic records/Audit trails and printout of the equipment's like autoclave, sterilizer, filter integrity machine and any other equipment's etc
To ensure the respective documents to be destructed as per approved procedure
To ensure the compliance and GDP of logbooks, online documents, records, and other supporting documents related to products manufactured in the plant and data integrity is ensured
To ensure & provide support to Shift Lead or Supervisor in investigation, in case of any product complaints or non-conformities or Out of Specification
To execute the approved Corrective and Preventive Action (CAPA) with in define timeline

What we offer

Apoyo a las padres
Educación continua/ Desarrollo profesional
Salud de los empleados y Beneficios de bienestar
Tiempo libre pagado
2 días al año para ser voluntario

Fulltime

Sr. Supervisor Quality Compliance

Baxter

Location:
United States , Irvine

Category:
Quality Control

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
April 27, 2026

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