Qa specialist i Job at Sensient Technologies Corporation (Biñan)

QA Specialist I

The QA Specialist will work with other departments to ensure the quality of prod...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a relevant scientific field
3-5 years of pharmaceutical or biotech industry experience
2+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production
Experience performing RCA, technical writing, and working with quality related investigations
Knowledge of laboratory and production equipment and IQ/OQ/PQ
Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9

Job Responsibility

Perform review of batch documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization
Review and approve master batch records for the timely initiation of GxP manufacturing activities
Responsible for quality oversight and administration of the deviation/investigation and CAPA programs
Review and approval of Manufacturing, Quality Control, and other investigations in support of batch release and GMP compliance
Provide direction for complex investigations and CAPAs
Ensure timely, accurate and complete execution and documentation of quality system events: deviations, NCMRs, GxP investigations and CAPAs
Review, develop, and improve quality system procedures, specifications, and test methods
Review and approve CAPAs to prevent recurrence of deviations
Review and approve Change Control documentation
Responsible for tracking investigations and change control for timely completion. Provide status reports, including relevant quality metrics and participation in the management review process

Fulltime

QA Specialist I - Operations

The QA Specialist will work with other departments to ensure the quality of prod...

Location

United States , Madison

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Experience performing RCA, technical writing, and working with quality related investigations
Knowledge of laboratory and production equipment and IQ/OQ/PQ
Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9
Bachelor’s Degree in a relevant scientific discipline preferred with a minimum of 3-5 years of pharmaceutical or biotech industry experience with 2+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production
ASQ certification preferred
Exceptional organizational skills and attention to detail
Ability to make risk based decisions and resolve issues with minimal guidance
Excellent interpersonal skills and the ability to communicate well orally and in writing
Proficiency in MS Office including Word, Excel, Access and Visio

Job Responsibility

Perform review of batch documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements
Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization
Review and approve master batch records for the timely initiation of GxP manufacturing activities
Responsible for quality oversight and administration of the deviation/investigation and CAPA programs
Review and approve Manufacturing, Quality Control, and other investigations in support of batch release and GMP compliance
Provide direction for complex investigations and CAPAs
Ensure timely, accurate and complete execution and documentation of quality system events: deviations, NCMRs, GxP investigations and CAPAs
Review, develop, and improve quality system procedures, specifications, and test methods
Review and approve CAPAs to prevent recurrence of deviations
Review and approve Change Control documentation

Fulltime

QA Specialist I - Training

The Training Specialist contributes to the maintenance, delivery and improvement...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

2+ years of previous experience in GMP environment
Experience with GMP quality systems in a pharmaceutical/biotech/medical device environment preferably aseptic manufacturing environment
Experience working with cross-functional teams and a results driven team player
Ability to multi-task in a dynamic environment with changing priorities
Bachelor’s Degree or equivalent related industry experience
Preference to degrees related to science, adult education or pharmaceutical processing
Basic eQMS/LMS system coordination, administration and/or data entry skills, preference to Master Control
Instructional Design knowledge, e-Learning Development capabilities and experience developing and delivering On The Job Training and assessment materials
Highly knowledgeable and skilled at pharmaceutical operations, including but not limited to: gowning, aseptic practices, formulation, fill/finish
Proficiency in MS Office including Word, Excel, Access and Visio

Job Responsibility

Support the manufacturing facilities and supporting functions for maintaining training requirements and needs by providing guidance and information on recommended training programs and providing routine customer service
Deliver On-The Job Training as deemed appropriate by management to support business needs and mentor trainees to competent and confident performance of new tasks
Develop, maintain and organize current and accurate training materials. This includes: On the Job Training, learning activities, handouts, checklists, worksheets, job aides and course evaluations and performance Qualifications
Deliver and / or facilitate instructor led training on GMP, technical skills, functional topics and others as deemed appropriate by QA Management
In conjunction with cross functional stakeholders assist with performing training needs assessment, develop courses and evaluations as assigned to support the business
Manage Training requirements, events and tasks in the eQMS (Master Control) for cross functional stakeholders. This may include training assignments for new hires or transitioned employees, new and revised documents or new programs
Determine the impact of process changes to current training materials and propose project plans to manage the updates
Assist with tracking of qualifications and training metrics by generating training reports
Writes and revises QA Standard Operating Procedures (SOP) under minimal supervision
Assists with training related actions associated with delivery of training in support of Quality Events (QEs)

Fulltime

QA Specialist I - Compliance

Reporting to the Director of Quality Systems & Compliance, the QA Specialist – C...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Associates degree plus 5 years of relevant experience or HS diploma and 10 years relevant experience
Minimum of 5 years of experience in office coordination, administrative support, or documentation management, preferably in a regulated industry such as pharmaceuticals or biotechnology
Intermediate ability to perform computer tasks and knowledge of various computer programs
Excellent communication skills, both written and verbal, with the ability to interact professionally with internal and external stakeholders at all levels
Ability to follow instructions and respond to management direction
Ability to work independently and/or as part of a team
Ability to display excellent time management skills
Ability to work in a dynamic, paced work environment
Ability to communicate clearly and concisely with cross functional staff, members of management and external clients
This position may require additional hours and/or weekend work

Job Responsibility

Provide comprehensive administrative support to the Director of Quality Systems & Compliance and the Compliance team
Coordinate all client and internal audits by securing conference rooms, scheduling meetings, obtaining and organizing documents, and ensuring a professional and welcoming environment
Order and maintain office supplies for the Compliance team, as needed
Manage the Compliance spreadsheets for tracking of all client and internal audit schedules
Manage the Compliance spreadsheets for tracking of all client and internal audit responses
Responsible for managing the transfer of client audit report observations to the PCI audit response templates
Provides support as directed by the Director of Quality Systems & Compliance and the Compliance team during FDA and other regulatory agency inspections
Provide continuous improvement support as directed by the Director of Quality Systems & Compliance and the Compliance team
Assist in follow up and tracking of client and internal audit commitments to assure timely closure as directed
Scan, store, and maintain documentation in electronic and physical filing systems, if applicable, ensuring accuracy, completeness and accessibility

Fulltime

QA Specialist (In-Home Care QA visits)

This position will be responsible for conducting in-home visits at clients' home...

Location

United States , Truth Or Consequences

Salary:

Not provided

Arcadia Home Care and Staffing - an Addus family company

Expiration Date

Until further notice

Requirements

Minimum of 3 years’ experience working in the field of senior services or a related social service field
Excellent oral and written communication skills
Strong interpersonal skills
Ability to prioritize and handle high call volumes
Client-focused and customer service-driven
Proficient in Microsoft Word, Excel, and Outlook
Must have reliable transportation, valid driver’s license and insurance for travel within the branch service area

Job Responsibility

Monitors client’s condition and performance of duties by Home Care Aides
Maintains all company and Department on Aging rules, regulations, and standards
Conducts home visits to new clients to welcome and review the Welcome Packet
Observes and evaluates Home Care Aides in the client's home as directed by Supervisor, to assure client Care Plans are being followed
Prepares and completes accurate evaluation reports and case notes as needed
Maintains schedules to assure timely completion of all assigned home visits
Attends weekly branch meetings
Maintains a high degree of confidentiality at all times due to access to sensitive information
Maintains regular, predictable, consistent attendance and is flexible to meet the needs of the department
Follows all Medicare, Medicaid, and HIPAA regulations and requirements

What we offer

Medical, Dental and Vision Benefits
Company matched 401K
Continued Education
Bonus
PTO Plan
Retirement Planning
Life Insurance
Employee discounts

Fulltime

Specialist QA, Global Supply Quality

In this role you will be serving patients through internal collaboration with Am...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree with 10 years of experience in manufacturing and quality management systems or a related field OR Bachelor’s degree with 12 to 13 years of experience in quality management systems or a related field
Minimum of 10 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations

Job Responsibility

Periodic review and updates to quality agreements to ensure alignment to Amgen expectations and to address needs depending on material type
Documentation review and approval including: supplier manufacturing records, investigation reports, Amgen quality records, and validation records (process & analytical)
Evaluation and documentation of raw materials and devices for changes to incoming inspection profiles
Oversight and completion of supplier assessments and documentation to support product complaints
Ownership of supplier metrics, performance assessments, and other key documents to inform the health of supplier relationships
Review and approval of change control records for supplier changes
Management of supplier audit records, ensuring on time completion and CAPA closeout activities are documented with appropriate closeout evidence
Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations
Take part in operational and quality improvement initiatives, programs, and projects
Develop solutions that are thorough, practical, and consistent with functional objectives

Fulltime

Cdd KYC Qa Specialist

This is Adyen: Adyen provides payments, data, and financial products in a single...

Location

Netherlands , Amsterdam

Salary:

Not provided

Adyen

Expiration Date

Until further notice

Requirements

3+ years of experience in CDD/KYC operational, QA, or compliance control oversight roles
Deep-seated understanding of AML/CFT frameworks and the regulatory nuances governing merchant onboarding and the wider customer lifecycle (including EDR and Terminations)
Exceptional English communication skills
Strong data analysis skills and the ability to synthesize complex information
Track record of working successfully cross-functionally with diverse stakeholders to drive various initiatives and process improvements to completion
You don’t just 'check' work—you own the outcome
You have an 'automation-first' mindset, naturally spotting manual bottlenecks and challenging existing processes to find a better way

Job Responsibility

Perform in-depth QA reviews with a core focus on CDD/KYC processes to identify systemic weaknesses before they become risks
Provide quality oversight as needed across other critical stages of the merchant risk lifecycle, including AML, Screening, Event Driven Reviews (EDR), and Terminations
Maintain the highest quality standards for merchant risk assessments, from initial Underwriting to periodic and event-driven reviews
Develop and maintain clear QA guidelines for analysts, ensuring that quality benchmarks are transparent, easily accessible, and strictly aligned with our global compliance procedures
Design and refine end-to-end QA frameworks that don’t just find errors, but actively facilitate the efficiency and accuracy of our operations
Coach MOPs leads and analysts to take ownership of their own quality
Translate QA findings into actionable dashboards and reports for leadership and compliance functions
Partner closely with 1st line, Compliance, Project Managers (Excellence team), and Product to drive continuous improvement and foster a global culture of shared quality and accountability

Fulltime

Specialist QA - Major Deviations

Let’s do this. Let’s change the world! In this vital role, you will serve as a Q...

Location

United States , Juncos

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree OR Master's degree and 2 years of Manufacturing Support and/or Quality Assurance experience OR Bachelor's degree and 4 years of Manufacturing Support and/or Quality Assurance experience OR Associate's degree and 8 years of Manufacturing Support and/or Quality Assurance experience OR High school diploma / GED and 10 years of Manufacturing Support and/or Quality Assurance experience

Job Responsibility

Provide Quality oversight to ensure clinical and commercial pharmaceutical products are manufactured, tested, stored, and distributed in compliance with cGMP and applicable regulations
Serve as Quality investigation lead and decision-maker for complex Major Deviations, maintaining accountability for investigation quality, timelines, documentation, and closure
Actively participate in deviation and RCA meetings, managing multiple concurrent deviations and driving effective resolution
Conduct thorough root cause investigations, including floor presence, process observation, and personnel interviews across shifts, including nights when required
Review, approve, and track cGMP documentation, including Deviations, CAPAs, CAPA Effectiveness Verification (EV), Change Controls, validations, and associated records
Demonstrate strong critical thinking skills, the ability to distinguish causal factors from root causes, and the ability to evaluate investigation quality using evidence-based decision making
Ensure that changes with potential impact to product quality are properly assessed and documented per established procedures
Verify that deviations from established procedures are investigated, documented, and resolved in accordance with Quality System requirements
Ensure production records, laboratory results, and investigation documentation are complete, accurate, and compliant with cGMP standards
Collaborate cross‑functionally with Manufacturing, Engineering, Validation, and Quality to implement effective and sustainable CAPAs

What we offer

Health and welfare plans for staff and eligible dependents
Financial plans with opportunities to save towards retirement or other goals
Work/life balance
Career development opportunities
Retirement and Savings Plan with generous company contributions
Group medical, dental & vision coverage
Life & disability insurance
Discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans and an annual site shutdown

Fulltime

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Qa specialist i

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Qa specialist i

QA Specialist I

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QA Specialist I - Compliance

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Specialist QA, Global Supply Quality

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Specialist QA - Major Deviations

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