Operations Specialist - QC Job at Wells Fargo (Hyderabad)

GMP QC Specialist, CMC

Reporting to the Director, QA Operations, the GMP QC Specialist, CMC, will be re...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in scientific discipline
Advanced degree preferred
Minimum of 5 years’ hands-on experience in biopharmaceutical technical operations, QC operations and/or quality operations
Minimum of 2 years’ hands-on experience in GMP laboratory environment, with specific familiarity with cell and gene therapy release assay development, performance, and qualification
Specific experience performing or reviewing microbiological assays, including compendial methods (sterility, endotoxin, mycoplasma assays, APS, APV and Environmental Monitoring)
Experience interacting with external testing laboratories preferred
Working knowledge of GMP and ICH guidance and both US and international regulatory requirements
Highly organized, effective, and proactive communicator verbally and in writing. Able to work independently to appropriately prioritize work
Strong team orientation and passion for continuous self-development
Experience in industry or in a startup industrial setting is preferred

Job Responsibility

GMP Compliance: Ensure that all internal laboratory activities are maintained in accordance with internal data integrity practices and standards. Ensure that external laboratory activities comply with GMP regulations and guidelines. Stay current with regulatory requirements and industry standards related to GMP
Batch Review / Release: Perform full batch record review of all types of investigations
perform appropriate quality control review of all QC data generated by third parties
draft, review, and approve CoA (internal/external)
Investigations: Identify issues of non-compliance and work directly with the third party to resolve prior to batch release. Review and approve any out-of-specification investigations in a timely manner
Quality Control Procedures: Develop, implement, and maintain quality control procedures to monitor and assess internal laboratory processes, as well as the processes employed by external laboratories used to generate QC data. Conduct regular reviews to identify areas for improvement and initiate corrective action(s) as needed
Audits and Inspections: Assist in the planning and conducting of internal audits to assess compliance with data integrity standards and approved procedures (e.g. SOPs, test methods). Support audits of external laboratories as needed
Assay Qualification / Validation: Review and approve assay development, qualification and validation plans, data generated and reports. Provide primary QC support for all activities
Documentation Management: Oversee the creation, review, and approval of laboratory documentation, including SOPs, test methods, protocols, and reports. Ensure that the documentation is accurate, complete, and in compliance with GMP requirements. Ensure all Process Development (Analytical Development and Manufacturing Sciences & Technology) related documentation and data are reviewed and archived in a timely and accurate manner
Training and Education: Assist in providing training and guidance to Process Development personnel on GMP principles, procedures, and compliance requirements. Ensure that all team members are informed and adhere to quality control measures

What we offer

health and retirement
PTO
stock option plans

Associate Quality Ops Tech (Vendor Inspection Coordinator)

The Associate Quality Ops Tech is an entry-level position, and their work is com...

Location

United Arab Emirates , Dubai

Salary:

Not provided

McDermott

Expiration Date

Until further notice

Requirements

High school diploma
2+ years of experience in Personnel Administration or related experience
Typing and working knowledge of MS Office
Effective interpersonal, verbal, and written communication skills

Job Responsibility

Assist Senior Quality Operations Specialist-Offshore QC Coordination in preparation, maintenance, and update of offshore assigned personnel schedule, safety training status, the readiness of travel documents, and arrangement
Maintain and update sub-contractor details, including inspection personnel approval, mobilization schedule, safety training status, travel tickets, weekly/monthly timesheet, follow-up of updated CVs, vacation schedule during the offshore assignment, and track record
Assist in preparation of weld consumable requisition in coordination with the welding engineering, maintain the track record of welding consumables being sent offshore as per project requirement
Arrange to send all welding consumables with relevant documents to the respective offshore locations/barge as per the guidance of the Senior Quality Operations Specialist/Welding Engineering
Follow-up QA/QC document/inspection equipment movement for the offshore project and handling over the respective personnel as per the direction and guidance of the Senior Quality Operations Specialist-Offshore QC Coordination
Prepare support documents and schedule as required to support the offshore activity as per the guidance of the Senior Quality Operations Specialist-Offshore QC
Ensure that the personnel data and visa request forms are accurately prepared and verified before submission for further process
Assist in arranging the air ticket and necessary visa for all offshore assigned personnel within the QC department as directed
Maintain a record of security gate passes issued for the sub-con personnel who are coming for the work/visit, arrange their safety induction and orientation training as applicable
Assist Principal Quality Operations Specialist-Offshore QC Coordination to verify vendor invoice and approval from Director Assurance and PMT by attaching Service Work Orders before forwarding submission to Accounts Payable for final clearance and payment

Clinical Laboratory QC Specialist

The Clinical Laboratory Quality Control (QC) Specialist I performs and functions...

Location

United States , Madison

Salary:

76000.00 - 125000.00 USD / Year

Exact Sciences

Expiration Date

Until further notice

Requirements

Bachelor’s degree in chemical, biological, or clinical laboratory sciences or medical technology from an accredited institution
For a degree not one of those listed above: 90 semester hours which must include 16 semester hours in chemistry (6 of which must be in inorganic chemistry)
16 semester hours in biology courses and 3 semester hours of math
2+ years of experience in a laboratory setting
1+ years of experience performing, reviewing and understanding quality control on a routine basis
Demonstrated ability to perform the Essential Duties of the position with or without accommodation
Authorization to work in the United States without sponsorship

Job Responsibility

All assigned job duties are performed following laboratory policies and procedures
Responsible for running daily QC scripts using statistical software and reviewing generated daily QC data
Responsible for identifying quality control issues, errors, and trends and promptly informing QC Specialist II and/or other QC team members of issues identified
May be requested to assist QC Specialist II and/or other QC team members in investigation of quality control issues, errors, and trends
May be requested to assist QC Specialist II and/or other QC team members in preparation of monthly quality control reports
Responsible for performing validations, verifications, and studies under the guidance of the QC Specialist II and/or other QC team members
Responsible for obtaining validation, verification, and study data for review
May be requested to assist in review of validation, verification, and study data
Assists QC Supervisor, QC Lead, and other QC team members in ensuring that all section turn-around times are maintained
Assists the QC Supervisor, QC Lead, and other QC team members by escalating concerns and answering technical questions from laboratory staff and others in Exact Sciences labs, as appropriate

What we offer

paid time off (including days for vacation, holidays, volunteering, and personal time)
paid leave for parents and caregivers
a retirement savings plan
wellness support
health benefits including medical, prescription drug, dental, and vision coverage
bonus eligible

Fulltime

Specialist, QC Systems

As the Specialist, QC Systems, you will support the design, implementation, and ...

Location

Canada , Vancouver

Salary:

76000.00 - 95000.00 CAD / Year

AbCellera Biologics

Expiration Date

Until further notice

Requirements

3+ years of experience managing quality systems in a GxP-regulated environment, with demonstrated application of global CMC/GMP requirements and relevant regulations and guidance
Bachelor’s degree in a relevant scientific or engineering discipline with 5+ years of industry experience in biotechnology, pharmaceuticals, or life sciences
Strong understanding and hands-on experience with quality management systems and continuous improvement principles, including their application to QC laboratory operations and regulated environments
Solid understanding of drug development processes from discovery through CMC development, with the ability to translate business and regulatory requirements into practical, compliant solutions
Experience supporting, configuring, or owning QC laboratory electronic systems (e.g., LIMS, LES, CDS) in a GMP-regulated environment, including system lifecycle management and change control
Proactive in identifying opportunities for improvement, with strong critical thinking and problem-solving skills

Job Responsibility

Supporting, maintaining, monitoring, and continuously improving the QC Quality Management System (QMS) framework and associated quality system processes in compliance with applicable global CMC/GMP requirements
Supporting the operation, administration, and lifecycle management of QC laboratory electronic systems (eSystems), ensuring they effectively support sample management, analysis, data acquisition, data review, and result reporting in compliance with global GMP, data integrity, and regulatory requirements
Contributing to the design, implementation, and evolution of the QC data architecture, identifying eSystem capabilities needed to support QC workflows, data integrity (ALCOA++), and phase-appropriate compliance
Supporting the Business Process Owner (BPO) for QC laboratory systems (e.g. LIMS, LES, CDS), overseeing system changes, enhancements, and upgrades throughout the system lifecycle
Overseeing and maintaining QC eSystems master data, including user roles, permissions, system configurations, and controlled data objects
Developing, reviewing, and maintaining GMP procedures, work instructions, controlled documentation, and training materials governing the compliant and effective use, administration, and data management of QC eSystems, including delivery of end-user training sessions
Providing QC eSystem support for investigations, deviations, and CAPAs, including data retrieval, audit trail review, and system impact assessments
Supporting qualification and computer system validation activities for QC systems (e.g., protocol and risk assessment review, validation deviations/exceptions, and lifecycle documentation)
Supporting QC eSystem licensing, user access, vendor relationships, and budgeting/forecasting for QC digital infrastructure
Collaborating cross-functionally with QC, Quality Systems, IT, Engineering, Validation, and external vendors to ensure QC eSystems are fit-for-purpose, compliant, and aligned with laboratory and business processes

What we offer

Equity
Annual bonus dependent on team and company performance
6% (non-match) RRSP contribution
CAD $1,500 annual Active Lifestyle Allowance
Annual vacation
Professional development opportunities
Comprehensive health benefits
Scientific and technical mentorship
Strong sense of community and connections through work, clubs, and socials

Fulltime

Associate Principal QA Specialist

Provide QA review and oversight for various studies and activities. Support a cu...

Location

United Kingdom , Slough

Salary:

32.76 GBP / Hour

SRG

Expiration Date

Until further notice

Requirements

Education/Degree: Field of Study Scientific
Work Experience: Quality (QA or QC) Level- Advanced - 5-10 years
QA Manufacturing experience
TrackWise records experience (Deviations, Change controls, CAPA's, investigations)
OOS investigations

Job Responsibility

Provide QA review and oversight for various studies and activities
Support a culture of quality and continuous improvement within QC and Development Services
Support Operations to ensure ongoing compliance with GMP
Manage and support GMP issues through QMS processes, site governance and senior QA leadership
Act as a GMP Subject Matter Expert (SME) by implementing, managing and enforcing quality processes on site
Support senior QA leadership in driving continuous improvement and ensuring processes are 'fit for purpose'
Ensure compliance with GMP requirements within Development Services
Maintain compliance with Regulatory Authority expectations, Global Quality Standards and customer requirements
Provide shoulder-to-shoulder review, approval and support for deviations, CAPAs, change controls, investigations and OOS records
Review QA activities for MSAT studies, pilot studies, and Development Services

Fulltime

QA Specialist II - Operations

The QA Operations Specialist II – Floor Support is responsible for providing QA ...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a relevant scientific field
Minimum 3 years’ experience in relevant GMP industry, with minimum 1 year experience in Quality, or Equivalent combination of education and experience
ASQ certification is a plus
Exposure to RCA, technical writing, and working with quality related investigations
Exposure to lean operation excellence highly desirable
Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
Knowledge and ability to apply basic scientific principles to solve operational, as well as routine quality tasks
Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9

Job Responsibility

Perform QA on-the-floor activities supporting client projects, including room release, auditing critical processes, reviewing GMP documentation in real time, and resolving issues that occur during manufacturing
Consult with internal teams such as Operations, QC, Facilities/Engineering, Project Management, and Materials Management to resolve complex situations or problems
Perform frequent walkthroughs and internal audits of manufacturing and support areas to ensure adherence to policies and procedures
Batch record review for adherence to internal procedures and Good Documentation Practices
Support the evaluation and disposition of intermediates, finish bulk drug substance and drug product
Review, approval and disposition of incoming materials such as consumables, excipients, and Active Pharmaceutical Ingredient
QA review and approval of new and revised GMP documents such as SOP’s and raw material specifications
Act as first responder for on the floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions
Co-ownership of nonconforming material investigations
Review of Quality Control environmental and utility monitoring data and test results

Fulltime

Sr. Specialist I, Product Quality Assurance

The Sr. Specialist I, NC Product Quality Assurance (PQA) will be responsible for...

Location

United States , Durham

Salary:

140000.00 - 185000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelors or Advanced degree in a scientific discipline with 10+ years' experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality
Knowledge of aseptic processing, and/or cell and gene therapy is preferred
Apply Quality concepts and company policies to resolve issues of moderate complexity in an effective manner
Excellent verbal and written communication skills, detail-oriented personality, and ability to work collaboratively across functions
Knowledge of global regulations and standards
Strong team player that has a customer service approach and is solution oriented
Attention to detail and the ability to work individually as well as within a multi-disciplinary team
Excellent listening, communication and interpersonal skills with a team focus
Consistent delivery of high-quality work
Ability to gown and work in a cleanroom environment

Job Responsibility

Provide Quality oversight of on-the-floor activities including manufacturing shop floor presence during operations
Provide Quality oversight of QC testing
Responsible for ensuring GMP compliance with applicable procedures and production requirements in QC, manufacturing, and facilities operations
Responsible for assisting with product disposition activities of supply produced at the manufacturing facility
Real time review of batch records and labels
Review and approval of manufacturing discrepancies and associated CAPA's
Communicating lot disposition pending issues to management
Aid in the development and ongoing improvement of applicable quality systems for the site
identifying gaps or improvements, authoring and approval of procedures, and providing training, as needed
Review and approve calibration and maintenance work orders and asset inductions

Fulltime

Specialist II, Product Quality Assurance

The Specialist, NC Product Quality Assurance (PQA) will be responsible for suppo...

Location

United States , Durham, NC

Salary:

105000.00 - 145000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelors or Advanced degree in a scientific discipline
10+ years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality
Knowledge of aseptic processing, and/or cell and gene therapy is preferred
Apply Quality concepts and company policies to resolve issues of moderate complexity in an effective manner
Excellent verbal and written communication skills, detail-oriented personality, and ability to work collaboratively across functions
Knowledge of global regulations and standards
Strong team player that has a customer service approach and is solution oriented
Attention to detail and the ability to work individually as well as within a multi-disciplinary team
Excellent listening, communication and interpersonal skills with a team focus
Consistent delivery of high-quality work

Job Responsibility

Provide Quality oversight of on-the-floor activities including manufacturing shop floor presence during operations
Provide Quality oversight of QC testing
Responsible for ensuring GMP compliance with applicable procedures and production requirements in QC, manufacturing, and facilities operations
Responsible for assisting with product disposition activities of supply produced at the manufacturing facility
Real time review of batch records and labels
Review and approval of manufacturing discrepancies and associated CAPA’s
Communicating lot disposition pending issues to management
Aid in the development and ongoing improvement of applicable quality systems for the site
identifying gaps or improvements, authoring and approval of procedures, and providing training, as needed
Review and approve calibration and maintenance work orders and asset inductions

Fulltime

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Operations Specialist - QC

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