Sr. Associate I, Quality Control Job at Baxter (Ahmedabad)

Sr. Associate I, Quality Control

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 investigate failure of finished product (FP) / In-process (IP) product, in case of any out of specification (OOS) / Laboratory error / deviation and take corrective and preventive actions
To ensure that preparation of reagents and volumetric solution and standardization on time
To perform periodic observation of retained sample
To initiate Change control (CcM), Non conformation report (NCR), Out of Specification (OOS), Document change record (DCR) etc.. QMS related documents
To do the work allocation in shift and ensure it complete within timeline
To assess the results of testing of In-process sample and finish products to ensure alignment with standard operating procedure (SOP) and regulatory guidelines
To review results of the tests against the specification & standard test procedure performed by team members
To investigate out of specification (OOS), Non-conformity and Laboratory Error Report (LER) related to In-Process Product Testing (IPPT) & Finished Product Testing (FP) and take corrective and preventive actions
To follow and ensure Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) inside QC
To ensure availability the working & impurities standards as per various pharmacopoeias

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. Associate I, Quality Control

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 investigate failure of finished product (FP) / In-process (IP) product, in case of any out of specification (OOS) / Laboratory error / deviation and take corrective and preventive actions
To ensure that preparation of reagents and volumetric solution and standardization on time
To perform periodic observation of retained sample
To initiate Change control (CcM), Non conformation report (NCR), Out of Specification (OOS), Document change record (DCR) etc.. QMS related documents
To do the work allocation in shift and ensure it complete within timeline
To assess the results of testing of In-process sample and finish products to ensure alignment with standard operating procedure (SOP) and regulatory guidelines
To review results of the tests against the specification & standard test procedure performed by team members
To investigate out of specification (OOS), Non-conformity and Laboratory Error Report (LER) related to In-Process Product Testing (IPPT) & Finished Product Testing (FP) and take corrective and preventive actions
To follow and ensure Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) inside QC
To ensure availability the working & impurities standards as per various pharmacopoeias

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. Associate Quality Complaints

Amgen is seeking a Sr Associate Quality Complaints owner and member of the Produ...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree
OR Bachelor’s degree and 2 years of Quality experience
OR Associate’s degree and 6 years of Quality experience
OR High school diploma / GED and 8 years of Quality experience
Fluency in verbal and written English to be able to understand & articulate technical concepts

Job Responsibility

Conducts low to medium complexity complaint investigations and determines if complaint investigations require escalation for further investigation
Evaluates and ensures triaged product complaint records comply with applicable procedures
Evaluates and owns complaint records with basic investigations
Ensures quality of complaint records
Completes assigned assessments per applicable procedures
Applies analytical skills to evaluate complex situations using multiple sources of information
Executes the complaint process per SOP requirements
Owns or manages the review/approval process flow in CDOCS of controlled documents
while adhering to format, content, and style guidelines, considering usability, and ensuring accuracy, consistency, and quality according to templates and style guide
Supports management of assigned projects or project tasks to achieve agreed deliverables within time and with expected quality, including (but not limited to) proactive written / in person communication, status updates, tracker & tool maintenance

Fulltime

Sr Associate QA I

Sr Associate QA I at Amgen in Holly Springs, North Carolina. This is an on-site ...

Location

United States , Holly Springs

Salary:

82081.95 - 111052.05 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school/GED + 4 years Quality Assurance, manufacturing and/or other regulated environment work experience OR Associate's + 2 years Quality Assurance, manufacturing and/or other regulated environment work experience OR Bachelor's + 6 months Quality Assurance, manufacturing and/or other regulated environment work experience OR Master's

Job Responsibility

Quality oversight of new product introduction activities covering facilities, utilities, equipment, systems and process with alignment into the Amgen Quality Systems
Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations
Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls
Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA), change control records and validations
Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements
Oversee and provide guidance during on-the-floor analytical testing
Ensure that changes that could potentially impact product quality are assessed according to procedures
Ensure that deviations from established procedures are investigated and documented per procedures
Alert senior management of quality, compliance, supply and safety risks
Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Sr. Manager Quality Control - Chemistry

At Amgen, if you feel like you’re part of something bigger, it’s because you are...

Location

United States , Holly Springs

Salary:

142103.85 - 192258.15 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED and 12 years of Aseptic Manufacturing experience OR Associate’s degree and 10 years of Aseptic Manufacturing experience OR Bachelor’s degree and 8 years of Aseptic Manufacturing experience OR Master’s degree and 6 years of Aseptic Manufacturing experience OR Doctorate degree and 2 years of Aseptic Manufacturing experience
In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.

Job Responsibility

Lead teams responsible for the QC Chemistry laboratory and 1st and 2nd shift Quality Control operations
Include the startup and validation of laboratory equipment, transfer and implementation of analytical methods, and development of a diverse team to support site startup and successfully transition into steady-state commercial operations at Amgen North Carolina
Overall responsibility for startup, operational readiness, and day-to-day management of the QC Chemistry laboratory and oversight of 1st and 2nd shift QC teams, including successfully transitioning the organization from site startup activities into routine commercial operations
Lead QC Chemistry functions supporting analytical method families including chromatography (HPLC/UPLC), capillary electrophoresis (CE), gel-based methods, and general compendial chemistry testing
Manage 1st and 2nd shift managers 7 days a week for cross functional night shift support for manufacturing
Ensure laboratory and shift operations are conducted in compliance with safety guidelines, cGLPs, cGMPs, and other applicable regulatory requirements
Build, lead, coach, and develop a high-performing organization capable of supporting both startup execution and long-term commercial manufacturing operations
Implement effective digital tools for leading the organization
Partner cross-functionally with Manufacturing, Process Development, Quality Assurance, Facilities & Engineering, Supply Chain, and other site functions to support startup readiness, process performance, and ongoing manufacturing operations
Participate in regulatory agency inspections and support site licensure and inspection readiness activities

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Sr Executive I, Quality Systems

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 archive master copy and superseded copy of documents in documents record room
To maintain data of document inventory and ensure all documents well-arranged and maintained in central record room as per SOP
To ensure proper storage and archival of documents in the Central record room
To maintain documents inventory for record room and to intimate the document owner on the due date of document retention period which is going to get due
To ensure access of central record room and BaxCabinet access for document process to required person as per request
To ensure departmental NCR initiate on time and prepare investigation report for NCR
To ensure closure of DCR/CCM/NCR/CAPA task within time frame
To ensure that all document records for doc-cell are in line with cGMP and regulatory compliance
To issue controlled copies of documents to the copyholders
To maintain blank logbook inventory and issue logbook and daily notebook based on request

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 Systems

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 archive master copy and superseded copy of documents in documents record room
To maintain data of document inventory and ensure all documents well-arranged and maintained in central record room as per SOP
To ensure proper storage and archival of documents in the Central record room
To maintain documents inventory for record room and to intimate the document owner on the due date of document retention period which is going to get due
To ensure access of central record room and BaxCabinet access for document process to required person as per request
To ensure departmental NCR initiate on time and prepare investigation report for NCR
To ensure closure of DCR/CCM/NCR/CAPA task within time frame
To ensure that all document records for doc-cell are in line with cGMP and regulatory compliance
To issue controlled copies of documents to the copyholders
To maintain blank logbook inventory and issue logbook and daily notebook based on request

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. QA Associate I

The Sr. QA Associate I is a Quality Subject Matter Expert whom ensures manufactu...

Location

United States , San Diego

Salary:

36.54 - 41.11 USD / Hour

PCI Pharma Services

Expiration Date

Until further notice

Requirements

High school diploma or equivalent required
Bachelor’s degree preferred in a Life Sciences discipline or equivalent relevant experience required
Minimum of four to six (4-6) years of experience in documentation, QA, Manufacturing, technical quality, validation, or equivalent
Working knowledge of cGMP regulations 21CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices and data integrity
Knowledge of Fill Finish and Biologics production environments preferred
Familiarity working with electronic batch records
Detail oriented and strong interpersonal and verbal communication skills

Job Responsibility

Identify, investigate, resolve, and prevent compliance/deviance issues by real-time review of batch records and walk-through of the manufacturing areas
Independently reviews and approves production batch records and associated data for product release and determines if records are within range of cGMP regulations and good documentation practices
Independently performs quality operations within multiple manufacturing departments
Participates in multiple process improvement projects
Develop, revise, review and approve controlled documents including standard operating procedures (SOPs), Master Batch Records, analytical methods, protocols and tech transfer forms
Reviews and approves executed technical documentation in support of the manufacturing and testing of Drug Substance and Drug Product. Represents QA for high profile clients
Provides quality oversight of quality reports including deviations, corrective and preventive actions (CAPAs) and risk management plan (RMP)
Provides quality support to clients by attending meetings as needed, addressing quality issues that arise, and advising clients on compliant solutions
Supports the Facility/Equipment/Process Change Control System including developing recommendations for change tasks, managing timelines, and performing follow-ups to evaluate the effectiveness of changes
Ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems

What we offer

eligibility for an annual performance bonus
paid time off
health insurance coverage (including dental and vision)
a flexible spending account
a 401(k) plan

Fulltime

Select Country

Sr. Associate I, Quality Control

Job Description

Job Responsibility

Requirements

What we offer

Looking for more opportunities?

Sr. Associate I, Quality Control

Sr. Associate I, Quality Control

Sr. Associate I, Quality Control

Sr. Associate Quality Complaints

Sr Associate QA I

Sr. Manager Quality Control - Chemistry

Sr Executive I, Quality Systems

Sr Executive I, Quality Systems

Sr. QA Associate I

Our AI answers in your language