Sr. Associate Compliance Job at Amgen (Seoul)

Sr. Associate, QA Compliance

As a member of the Baxter Quality team, you will play an essential part in our m...

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Detail Oriented
Continuous Learner
Courageous
Collaborative
Critical Thinker
Influential
External Inspection
Compliance
Audits

Job Responsibility

External Inspection
Compliance
Audits

What we offer

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

Fulltime

Sr. Associate Manufacturing Production Process Owner

In this vital role you will partner with cross-functional teams—including Engine...

Location

United States , Thousand Oaks

Salary:

92002.00 - 108605.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school/GED + 4 years Manufacturing support experience
Associate’s + 2 years Manufacturing support experience
Bachelor’s + 6 months Manufacturing support experience
Master's
Advanced degree (Master’s or Ph.D.) in Engineering, Biotechnology, or related field
Experience in aseptic Drug Product or biologics manufacturing
Knowledge of process validation, deviation management, and change control
Strong analytical and problem-solving skills with experience using data visualization tools (Spotfire, JMP, Excel)
Excellent written and verbal communication skills and ability to collaborate across functions

Job Responsibility

Initiate, revise, and approve controlled manufacturing documents within Amgen’s electronic document management system (CDOCs)
Serve as document author, owner, reviewer, or data verifier, ensuring accuracy and compliance with current GMP and Amgen standards
Maintain documentation to accurately reflect operational practices and regulatory requirements
Support implementation of new processes, equipment, and major initiatives within Drug Product operations
Collaborate with Capital, Engineering, Process Development, Quality, and other functions to define requirements and achieve operational readiness
Assist in developing and implementing SOPs, batch records, training, validation, and automation configurations
Analyze manufacturing data and performance metrics to identify trends, deviations, and opportunities for improvement
Develop and implement data-driven solutions to improve yield, reliability, and compliance
Support data monitoring using analytical tools such as Enterprise Data Lake and Spotfire, ensuring configuration alignment with process design and GMP requirements
Support timely investigation and resolution of manufacturing deviations

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. Associate, Data Analyst – Internal Audit

This role supports the Head of Internal Audit, and the Sr. Associate will be ins...

Location

United States , San Rafael

Salary:

89600.00 - 123200.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

Bachelor’s degree required
One of more of Certified Internal Auditor, Certified Information Systems Auditor, or Certified Fraud Examiner designation preferred
3-5 years in internal audit, Compliance, Legal, advisory or global corporation, or a combination hereof
Biotech/Pharmaceutical/Life Science experience preferred
Proficiency or working knowledge of MS Copilot, Analyst, Researcher Agents
Proficiency in data analytics tools (e.g., SQL, Python, R, Alteryx) and visualization platforms (e.g., Tableau, Power BI)
Experience working with ERP systems (e.g., SAP, Oracle) and audit management tools
Excellent analytical, problem-solving, and communication skills
Ability to work with ambiguity, and respond to a rapidly changing, highly innovative environment
Candidate must be skilled and exhibit professional savvy and ability to interact with various levels of management

Job Responsibility

Participate in audit scoping discussions with cross-functional teams
Design and implement data analytics procedures that support audit scoping activities
Coordinate with external subject matter experts
Identifies and collects applicable data to support audit testing
Performs analytics testing
Creates the initial audit testing workbook
Collects relevant data / system reports
Analyzes large datasets to identify patterns, outliers, and potential issues
Documents conclusions from testing
Communicates results of audit testing

What we offer

Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

Fulltime

Business Risk and Control Sr Analyst

The Business Risk and Control Sr Analyst is a seasoned professional role. Applie...

Location

Philippines , City of Taguig

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

5-8 years of experience
Experience with work-flow systems
Excellent project management and organizational skills
Outstanding relationship building and relationship management skills
Consistently demonstrates clear and concise written and verbal communication skills
Proficient in Microsoft Office with an emphasis on MS Excel
Self-motivated and detail oriented

Job Responsibility

Help coordinate governance and the facilitation of the execution of the Manager Control Assessment (MCA)
Assist in contributing to the quality, completeness, and accuracy of the implementation of the Control Framework
Provide support in the identification of issue root cause
Support on the implementation of the Lessons Learned Policy
Influence decisions on the review and challenge process
Perform analysis to support with the timeliness, accuracy and completeness of the MCA through controls
Support and contribute to Operational and Compliance Risk
Work with the team to identify, assess, escalate, and manage risk exposures
Perform analysis to support Risk Appetite
Provide support to identify, assess, record and response to Operational and Compliance Risk events

Fulltime

Mq ts downstream associate

The MQ TS Downstream Associate is responsible for primary contact of quality on ...

Location

India , Vizag

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

M. Pharma / Msc with more than 1 year experience in Manufacturing Quality Assurance / Quality Assurance / Production of a pharmaceutical manufacturing facility
Experience in the pharmaceutical industry and Quality administered systems
Sound knowledge of current Good Manufacturing Practices (part of GxP)
Ability to work effectively in a team environment, both within one's own team and interdepartmental teams
Effective written and oral communication skills.

Job Responsibility

Responsible for ensuring operating state of cGMP compliance in Terminal Sterilization, Visual Inspection and Packaging operations
Maintain regulatory compliance in accordance with cGMP practices
Ensure manufacturing policies and procedures conform to Pfizer standards
Knowledge and hands on experience in reviewing eBR and assessing the impact of AMPs exceptions with technical support/inputs from Sr. Associate or Sr. Team Leader
Review of Batch reports and Equipment audit trails
Perform Acceptable Quality level sampling, Inspection in VIDT and Batch record review and release
Perform batch start-up and end activities viz. sensor challenge tests, recipe review etc
Perform random process checks for Terminal Sterilization, Visual Inspection and Packaging
Perform Daily walkthroughs and report observations to the Sr. Team Leader
Perform Equipment breakdown assessments w.r.t to Product Quality and patient safety with technical support/inputs from Sr. Associate or Sr. Team Leader

Fulltime

Cross-disciplinary Controls Sr. Lead Analyst

This role involves managing operational risk and control processes with a strong...

Location

Colombia , Bogotá

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

15+ years of experience in operational risk management, compliance, audit, or other control-related functions in the financial services industry
Ability to identify, measure, and manage key risks and controls
Track record leading Control related projects and programs
Ability to see the big pictures with high attention to critical details
Develop and implement strategy and process improvement initiatives
Comprehensive knowledge of Citi’s businesses and functions and their risk profiles
Developing new ideas and improving current processes to proactively mitigate risks
Requires an ability to provide challenge and make recommendation for risk and controls remediation
Expert knowledge in the development and execution for controls
Proven experience in control related functions in the financial industry

Job Responsibility

Develop and maintain robust MIS reports and dashboards to monitor key risk indicators (KRIs) and control performance indicators (CPIs)
Provide insightful analysis of risk data to support strategic decision-making
Contribute to the development and implementation of AI governance frameworks, ensuring ethical use, transparency, fairness, and accountability of AI systems
Perform assurance activities over AI models and their associated data
Stay abreast of industry trends in risk management, MIS technologies, and artificial intelligence to continuously enhance risk and control capabilities
Support the safe growth and management of the Citi Markets business line and its associated higher risk segments through robust risk mitigation
Identify and assess risk, vulnerabilities, and opportunities for efficient and effective risk coverage
Work within team and across business/functional line management to assess complex issues, structure potential solutions, and drive effective resolution within permissible statutory and regulatory frameworks
Evaluate and respond to escalated matters and further escalate as required
Advise senior management on next steps as needed

What we offer

Global benefits to support well-being, growth and work-life balance.

Fulltime

Sr Environmental Lead

The Environmental Leader is responsible for ensuring the existence of an environ...

Location

United States , Newark

Salary:

Not provided

Owens Corning

Expiration Date

Until further notice

Requirements

5 years of experience working in an industrial or manufacturing environment preferred
Bachelor’s degree required
Degree in Environmental discipline is strongly preferred, engineering, business management or related discipline
Management Systems experience is a plus
Understanding of manufacturing process is a plus
Leading change management efforts
Forward thinking leadership abilities including the ability to motivate, lead by example and encourage teamwork and effective communication
Past work with Government Regulatory agencies is beneficial
Experience with computer programs like Excel, Word, Aspentech, Ignition, Access, is beneficial
Experience with management systems is beneficial

Job Responsibility

Guide the Plant in developing risk-ranked strategic plans, prioritize and advocate capital/resource requests, and advise the leadership team on all aspects of environmental requirements and responsibilities
Drive and maintain compliance with Environmental Compliance Approvals (ECA), plans and deviation reporting
Develop, implement, track and test environmental programs such as air and water compliance, above-ground and underground storage tanks, spill prevention and control, hazardous waste and materials management, solid waste recycling and employee training
Safely and cost effectively leads the ongoing internal captive landfill operations by providing daily direction to the contractor(s), ensuring all permitting and monitoring requirements are in compliance
Provides ongoing technical support to the Plant’s wastewater processing systems, ensuring all permit, reporting and monitoring requirements are in full compliance
Develop and maintain environmental monitoring and recordkeeping to satisfy requirements of the plant’s ECAs/plans
Knowledge of key required Environmental recordkeeping or reporting tools like
OEPA’s EBIZ system, CDX, SharePoint sites, Dakota Profiler, Resource Advisor, etc
Lead and support Environmental initiatives and processes to drive towards zero non-conformities and/or NOV’s
Leads Plant’s efforts to meet Corporate Sustainability goals, with emphasis on Energy, Water and Waste-to-Landfill reduction aspects