Sr Associate, Manufacturing Regulatory Job at Alfasigma (Pomezia)

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

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

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

Sr. Fsqa Manager

Lead the manufacturing facility Food Safety & Quality Assurance department and c...

Location

United States , Oakland

Salary:

Not provided

Ajinomoto Foods North America, Inc.

Expiration Date

Until further notice

Requirements

BS degree in Food Science, Microbiology, Biology or equivalent is required
10+ years Quality Control/Quality Assurance experience in USDA food manufacturing environment with at least half of the experience being in a supervisory capacity is required
Frozen food experience preferred, but not mandatory
Certifications through ASQC, SQF, GFSI and other professional quality associations are helpful
Budget/Cost Control – general understanding of QA/procurement budgeting and cost control functions
Presentation Skills – ability to make clear, concise and convincing business presentations
Analytical – ability to independently perform, mentor and manage others in conducting complex technical analysis of manufacturing data, statistical process control (SPC) and supplier performance
Leadership – ability to act as team leader for special task assignments
Mentoring – ability to mentor other QA team members in technical knowledge and QA management skills
Communication Skills – excellent verbal and written communication skills, including technical writing and presentation skills

Job Responsibility

Lead the manufacturing facility Food Safety & Quality Assurance department and carry out management responsibilities in accordance with Ajinomoto policies, procedures and applicable regulatory laws
Lead all regulatory compliance requirements
training and managing associates
establishing audit-ready procedures for the facility
record-keeping
laboratory management
maintaining quality, food safety and sanitation parameters of AWI products and facilities
have an understanding of labeling, exports and RTE and NRTE food manufacturing and sanitation processes
Fully implement and manage all AWI FSQA policies and procedures regarding food safety and quality
Develop, implement and manage new and on-going quality assurance and food safety training programs at the facility

Fulltime

Sr Manufacturing Associate, Downstream

Be the driving force behind seamless logistics with our client where precision a...

Location

United States , Bristol

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Bachelor's degree in chemistry, biology or engineering
A minimum of 6+ years' experience in a GMP pharmaceutical environment
Experience in normal flow filtrations and tangential flow filtrations (UF/DF)
Experience with optimization of bioprocesses
Direct hands-on experience with preparative chromatography systems (AKTA Pilot, AKTA Ready, AKTA Explorer, etc.), and manual or automated TFF skids
Experience with cGMP manufacturing operations and GxP principles
Understanding and application of cGMP requirements

Job Responsibility

Works in GMP environment and ensures regulatory compliance
Performs Manufacturing activities including: Performs a variety of complex tasks in accordance with cGMP, cGDP, SOPs, and Batch Records
Batch Documentation/Record Generation
Materials sampling, staging, dispensing, and return
Equipment and Room set-up, operation, and cleaning
Use of appropriate personal safety equipment and engineering controls
In-process inspection and sampling
Support investigational and quality systems activities
Assist maintenance in the performance of preventative maintenance activities, troubleshooting and repair of equipment
Participate in continuous improvement activities

Fulltime

Sr. Accountant

In this role, you will oversee all accounting, finance, and costing functions in...

Location

United States , Fife

Salary:

80000.00 - 95000.00 USD / Year

Robert Half

Expiration Date

Until further notice

Requirements

Proficiency in Account Reconciliation
Experience with Balance Sheet Reconciliation
Ability to perform Bank Reconciliations
Knowledge of General Ledger
Experience in creating and posting Journal Entries
Proficiency in Microsoft Excel
Experience in Month End Close processes
Understanding of Job Cost methods
Experience in Manufacturing Cost Accounting
Proficiency in Cost Analysis

Job Responsibility

Oversee and maintain the general ledger
Review and analyze CapEx requests and maintain the fixed asset sub-ledger
Implement procedures to improve efficiency and reporting accuracy
Work with the operations team to ensure accurate BOMs and routers for finished goods
Verify the accuracy of monthly COGS
Manage monthly/quarterly tax filings, annual business licenses, and property tax filings
Contribute to the development and maintenance of accounting policies and procedures
Analyze and allocate manufacturing costs, establishing standards, and reviewing cost variances
Oversee accuracy in payroll operations, including timesheet reconciliation
Prepare and review journal entries, reconciliations, and supporting documentation

What we offer

medical
dental
vision
life and disability insurances
participation in the company’s 401(k) plan with 6% match
15 days of paid vacation
5 days of paid sick leave
9 paid holidays per calendar year

Fulltime

New

Sr. Manufacturing Manager

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

Puerto Rico , Aibonito

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree required - MBA preferred - 10+ years manufacturing/operations experience including 3 years of leading leaders
Fully bilingual in English and Spanish, with the ability to effectively communicate—both verbally and in writing—in both languages
Demonstrated ability to read, analyze, and interpret scientific and technical journals, financial reports, and legal documents
Skilled in responding to inquiries or concerns from customers, regulatory agencies, and members of the business community in a professional and timely manner
Strong professional writing and communication skills including reports, presentations, speeches, and articles, ensuring alignment with established style and format standards
Proven capability to clearly present complex information to diverse audiences
Lead multiple priorities in a manufacturing plant setting
analyze and draw conclusions from scientific and statistical data
Apply data analysis to solve problems and make strategic decisions
understand GMPs and other applicable regulatory guidelines and ability to handle audit-related activities

Job Responsibility

Establishes, or recommends to management, major corporate manufacturing strategies, objectives, and policies for company
Support the rollout of a Total Predictive Maintenance program to minimize equipment failures associated to predictable tendency
Review production timetables and manages manufacturing activities to ensure production schedule adherence and quality of products align with specifications
Reviews manufacturing engineering performance reports and resolves technical and upkeep issues to ensure minimum costs and prevent operational delays
Directs preparation of budgets, reviews budget proposals, and prepares necessary supporting documentation and justification
Drive value improvement programs
Reviews production schedules to ascertain product data such as types, quantities, and specifications of products and scheduled delivery dates in order to plan department operations
Plans production operations, establishing priorities and sequences for manufacturing products
Prepares operational schedules and coordinates production processes to ensure that the quality and output of products meet specifications
Reviews production and operating reports and addresses operational, manufacturing, and maintenance problems to keep costs low and avert operational delays

What we offer

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
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

Sr. Environmental Leader

GM is seeking a Sr. Environmental Leader who is passionate about leading the env...

Location

Canada , Oshawa

Salary:

97800.00 - 146600.00 CAD / Year

General Motors

Expiration Date

Until further notice

Requirements

Minimum 5 years experience in environmental engineering or related science or engineering field, experience in manufacturing preferred
Bachelor’s Degree is preferred, preferably in engineering or related environmental sciences
P. Eng preferred
Demonstrated understanding of provincial, federal and municipal environmental regulations and the ability to interpret how those regulations apply to site operations and activities
Demonstrated expertise in at least one environmental media (air permits and regulation, water permits and regulation, and/or waste regulations)
Expertise to investigate complex environmental problems and apply sound technical judgment to develop possible solutions
Highly developed oral and written communications skills
Experience with analytical problem-solving skills and the ability to communicate complex data or situations so that others, including senior leadership, can comprehend, respond and contribute
High level of enthusiasm, persistence, leadership ability, initiative, and experienced judgment to identify priorities, initiate projects, and complete activities in a timely fashion
Experience working externally with regulators or other public or private sector individuals

Job Responsibility

Ensure the site meets all Environmental Compliance Approval requirements as it relates to equipment operating conditions, emissions modeling (ESDM), change management, and regulatory reporting
Review and validate new chemicals or process changes meet regulatory guidelines
Track completion of preventative maintenance on key equipment
Complete and submit required regulatory reports such as NPRI and GHG
Provide contract management oversight to the sites Chemical Manager including safety oversight, annual budgeting, invoice tracking and more
Ensure the site meets all Environmental Compliance Approval requirements as it relates to waste management
Provide contract management oversite to the sites Resource Manager including safety oversight, annual budgeting, invoice tracking and more
Ensure all waste being generated as part of the manufacturing operation is characterized and shipped in accordance with provincial and federal regulations
Ship soil in accordance with Ontario soil management regulations
Identify and implement continuous improvement initiatives that improve the sites diversion rate, drive down non-diverted waste totals, and help meet the site’s Zero Waste objectives

What we offer

Paid time off including vacation days, holidays, and supplemental benefits for pregnancy, parental and adoption leave
Healthcare, dental and vision benefits including health care spending account and wellness incentive
Life insurance plans to cover you and your family
Company and matching contributions to a Defined Contribution Pension plan to help you save for retirement
GM Vehicle Purchase Plan for you, your family, and friends

Fulltime

Sr Associate, Manufacturing Regulatory

Alfasigma

Location:
Italy , Pomezia

Category:
IT - Administration

Contract Type:
Employment contract

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
April 24, 2026

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