Senior Associate, Quality Compliance Job at Amgen (Hyderabad)

Senior Associate, Quality Compliance

The senior associate will work within R&D Quality’s Business Intelligence and Da...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree and 7-10 years in Pharma and Biotechnology R&D Quality
Bachelor’s degree and 10-15 years of years in Pharma and Biotechnology R&D Quality
Exceptional attention to detail and accuracy in all deliverables
Ability to work independently and proactively in a fast-paced environment
Proficiency with Tableau or similar data visualization tools
Proficiency with Python or other object-oriented programming language
Proficiency with SQL and Databricks
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and virtual collaboration tools (e.g., Teams)
Effective communication, critical thinking and problem-solving
Experience in conducting data analyses and translating data sets into actionable insights

Job Responsibility

Extract and clean data from internal systems for regular and ad hoc reporting, including data pipeline creation and maintenance
Generate, validate, and deliver KPIs, quality metrics, and performance indicators used across the R&D Quality landscape
Investigate and analyze metric trends, anomalies, and operational insights
Design, build, and maintain Tableau dashboards for operational monitoring, compliance reporting, and executive summaries
Develop and maintain Python scripts used for data processing, transformation, and report automation
Help create reusable components for common data analysis tasks and documentation
Ensure version control and proper documentation of scripts and workflows

Senior Associate Quality Assurance

The Sr. Associate Quality Assurance position supports Amgen’s Quality Assurance ...

Location

United States , Thousand Oaks

Salary:

82081.95 - 111052.05 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school/GED + 4 years of GMP experience OR Associate’s + 2 years of GMP experience OR Bachelor’s + 6 months of GMP experience OR Master's
Bachelor’s Degree in Biochemistry, Biology, Chemistry, or related science field
Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices
Experience managing projects through to completion meeting timelines
Ability to evaluate documentation and operations according to company procedures
Experience working with Quality Systems
Strong organizational skills and ability to manage multiple tasks at one time
Effective communication skills (both written and verbal)
Demonstrated ability to work as both a team player and independently
Display leadership attributes and drive improvement initiatives

Job Responsibility

Purposeful presence on the manufacturing floor (Form/Fill Grade 8 Gowning), 100% Manual
Visual Inspection support, ASP/AQL performance, and QA Oversight Assessments
Electronic batch review
GMP Document (SOPs/FORMs) revision review/approval
Review and approval of electronic Maintenance documentation Work Order/Job Plans
Quality support and approval of minor deviations
Electronic Batch Record (MES) documentation revisions and approvals
Evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion
Flexibility with shift work (including weekends) and comfortable with gowning requirements to support 24/7 production in a Grade 8 (Clean Room) Drug Product filling facility

What we offer

Retirement and Savings Plan with generous company contributions
group medical, dental and vision coverage
life and disability insurance
flexible spending accounts
discretionary annual bonus program
stock-based long-term incentives
time-off plans
flexible work models

Fulltime

Senior Associate Quality Assurance

The Senior Associate QA will be required to perform 12-hour shift (rotational ni...

Location

Singapore , Singapore

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Masters Degree OR Bachelor's Degree and 2 years of directly related experience OR Associate's Degree and 6 years of directly related experience OR High School Diploma / GED and 8 years of directly related experience
Preferred 5+ years of relevant work experience in the commercial manufacturing environment within the pharmaceutical / biologics industry and understanding of GMP pharmaceutical production, biological drug substance experience and operation
Experience with batch record review, and quality record support
Experience in pharmaceutical equipment operation, design and control including GMP change control
Experience in providing floor support, troubleshooting unit operations, and resolving and documenting investigations to support cGMP production
Understanding of equipment log review and continuous monitoring requirements
Good communication skills (technical writing and verbal communication/presentation)
Interacts effectively with variety of communication and working styles
Experience with regulatory audits and inspections
Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality

Job Responsibility

Conduct Quality Assurance activities related to quality floor support for solution and equipment preparation, cell culture and product purification & Drug Substance Filling operations
Support of electronic batch record review and approval, change control, investigations and product release
Work in a cross functional team with Process Development, Manufacturing, Supply Chain, Engineering and Facilities to ensure product quality and market supply
Role may include participation in new product introductions, additional equipment, installation commissioning, qualification
Support continuous improving initiatives

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Senior Associate – Compliance Solutions

The Senior Associate within the Waystone Compliance Solutions Services function ...

Location

Singapore , Singapore

Salary:

Not provided

Waystone Governance Ltd.

Expiration Date

Until further notice

Requirements

Minimum of 2-3 years’ experience in asset management / financial services compliance for MAS regulated entities
Must be able to work in a fast-paced
Fluent in English (written and spoken)
Proficient in MS Office (Word, Excel, Outlook, and Teams)
Minimum university or equivalent education

Job Responsibility

Be directly responsible for providing ongoing compliance support services to a portfolio of clients
Strong attention to details and keen on delivering quality work
Strong interpersonal and communication skills (both written & verbal)
Relationship Management - Provide service excellence to internal and/or external clients
A team player, enthusiastic, and self-motivated
Analytical skills - collect and analyze information, problem-solving, and make decisions under minimal supervision
Commercial awareness and understanding of business environments
Assisting with AML screening of customers and conducting risk assessments in a timely manner
Providing day-to-day support to clients and colleagues in executing AML and other compliance related matters for clients
Develop, initiate, maintain, and revise policies and procedures to ensure compliance with various regulatory requirements

Fulltime

Senior Associate Quality Assurance

The Incoming Quality Assurance (IQA) Associate position will provide support for...

Location

Singapore , Singapore

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Masters Degree OR Bachelor's Degree and 2 years of directly related experience OR Associate's Degree and 6 years of directly related experience OR High School Diploma / GED and 8 years of directly related experience
5 years of experience in regulated environment
Experience and basic troubleshooting skills with laboratory and process equipment
Experience with LIMS, SAP, TrackWise, Veeva
Ability to understand, apply and evaluate basic chemistry
Ability to adhere to regulatory requirements, written procedures and safety guidelines
Ability to evaluate documentation/data according to company and regulatory guidelines
Ability to interact with inspectors (internal and external)
Ability to interpret and apply Good Manufacturing Practice (GMP) knowledge
Ability to organize work, handle multiple priorities and meet deadlines

Job Responsibility

Comply with safety guidelines, cGMPs (Good Manufacturing Practices) and other applicable regulatory requirements
Complete required assigned training prior to execution of required tasks
Perform raw material inspection, sampling and rapid ID testing in accordance to written SOPs and Methods.
Generate complete and accurate documentation using electronic or handwritten systems.
Review records to ensure raw materials are tested and inspected according to specification and SOPs
Perform business operations related to inspection/sampling/testing (i.e updating dashboards, relevant metrics, housekeeping, inventory management, audit support)
Support site/network Continual Improvement initiatives
Ensures facilities, equipment, materials and procedures comply with cGMP practices and other applicable regulations
Alert management of quality, compliance, supply and safety risks in a timely manner
Participate in raw material issues or deviations

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Senior Associate Quality Assurance

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

United States , New Albany

Salary:

82081.95 - 111052.05 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school/GED + 4 years quality work experience
Associate’s + 2 years quality work experience
Bachelor’s + 6 months quality work experience
Master's
Bachelor’s degree in Life Sciences, Engineering, or related field
1+ years of experience in Quality Assurance within a GMP environment (biotech/pharma preferred)
Strong knowledge of cGMP regulations and industry best practices
Experience with batch record review, and deviations
Ability to work flexible shifts, including evenings, nights, weekends, or holidays as needed
Excellent communication, problem-solving, and organizational skills

Job Responsibility

Providing on-the-floor QA support for manufacturing activities across assigned shifts
Ensuring adherence to GMP regulations and internal quality standards
Reviewing and approving batch records, logbooks, and quality documentation
Supporting deviations
Partnering cross-functionally with Manufacturing, QC, and Engineering teams
Identifying opportunities for continuous improvement and operational excellence
Acting as a quality advocate, promoting a culture of compliance and accountability

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

Fulltime

Quality Compliance Senior Manager

As part of the GxP Quality Management System (QMS) architecture, the GMP/GDP Ins...

Location

United States , Remote

Salary:

132037.30 - 178638.70 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector
Master’s degree and 4 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector
Bachelor’s degree and 6 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector
Associate’s degree and 10 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector
High school diploma / GED and 12 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector

Job Responsibility

End‑to‑End Inspection Process Ownership
DQMS Business Ownership
Cross‑GxP Inspection Alignment
Metrics, Monitoring & Management Review
Governance, Compliance & Continuous Improvement

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

Senior Compliance Associate I

The Sr. Compliance Associate I will utilize their skills to hosts customer and r...

Location

United States , San Diego

Salary:

40.92 - 46.04 USD / Hour

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Bachelor's Degree in a Life Sciences discipline or equivalent relevant experience required
Minimum of 6 years of relevant QA experience in a regulated industry
At least two (2) years relevant experience of manufacturing in a GMP environment or Drug Product Manufacturing Preferred
Advanced-level understanding of regulatory requirements related to aseptic drug product manufacturing and testing
Knowledge and hands on experience with QMS data management software such as ACE, Track Wise, Master Control, ETQ, etc.
Highly effective in collaborating with internal and external customers, leading improvement projects, and training team members on internal and external auditing
Detail-oriented with strong organizational skills

Job Responsibility

Leads customer audits, collaborates with Subject Matter Experts to address audit findings, and tracks the customer audit program for continuous improvement
Supports vendor management program, occasionally conducts on-site and paper audits, and establishes Quality Agreements
Supports the execution of internal audit program
Supports risk management program
Supports the continuous improvement of the Quality Management System
Reviews and approves quality management system standard operating procedures (SOPs)
Reviews and approves deviation reports and CAPAs related to quality systems
Generates quality system metrics for management review meetings
Trains team members on conducting internal and external audits
Regular and reliable attendance on a full time basis

What we offer

Paid time off
Health insurance coverage (including dental and vision)
Flexible spending account
401(k) plan
Eligibility for an annual performance bonus

Fulltime

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Senior Associate, Quality Compliance

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