Quality Investigator Job at Aspire of WNY (Getzville, NY)

Specialist-Manufacturing Investigations

In this vital role, you will be a key member of the team that investigates major...

Location

United States , Holly Springs

Salary:

114990.00 - 139433.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED and 10 years of Quality Control experience
Associate’s degree and 8 years of Quality Control experience
Bachelor’s degree and 4 years of Quality Control experience
Master’s degree and 2 years of Quality Control experience
Doctorate degree

Job Responsibility

Manage Major deviation investigations, including assembling investigation teams, leading root cause analysis, development of CAPAs, and compliant documentation of all findings
Drive improvements to the investigation process
Present investigations to regulatory inspectors, internal auditors, and management
Clearly communicate investigation progress to impacted areas and leadership
Coordinate and effectively lead cross-functional teams through complex investigations, and complete milestones on-schedule
Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues
Build effective relationships across functions
Navigate through ambiguity and provide a structured problem-solving approach
Apply inductive and deductive reasoning in the investigation process
Clear and concise technical writing

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

Quality Analyst/Investigator

This position would be responsible for conducting investigations of untoward inc...

Location

United States , Getzville

Salary:

19.08 - 24.81 USD / Hour

Aspire of WNY

Expiration Date

Until further notice

Requirements

Skilled in the principals of investigations and audits including analytical skills, interview skills, and excellent writing and verbal communication skills
Bachelors Degree
3 years experience in OPWDD/Medicaid Audits, medical reviews, quality assurance/improvement or regulatory compliance

Job Responsibility

Conducting investigations of untoward incidents of Abuse/Neglect, Significant Incidents, Serious Notable Occurrences, Minor Notable Occurrences, or unusual incidents for all Aspire of WNY programs
Writing investigation reports
Conducting quality reviews

What we offer

Medical insurance thru Independent Health
Dental insurance
FSA
100% agency paid life insurance
Both long term and short term disability insurances
403b retirement plan with Agency match
Continuing education reimbursement
15 paid holidays
Separate sick, personal and vacation time

Fulltime

Quality and Compliance Manager

The Quality & Compliance Manager oversees quality assurance operations for JLL's...

Location

United States , Summit, NJ; Warren, NJ

Salary:

95000.00 - 115000.00 USD / Year

JLL

Expiration Date

Until further notice

Requirements

Bachelor's degree in Science or Engineering
Minimum 3 years of experience in quality engineering, facilities operations, or production operations in a cGMP environment
Prior experience working in an FDA-regulated bio-pharmaceutical manufacturing facility
Knowledge of FDA regulations 21 CFR Parts 210, 211, or Part 820
Understanding of current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP)
Experience with quality management systems including investigations, CAPAs, audit programs, and vendor qualification
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
Candidates must be authorized to work in the United States without sponsorship

Job Responsibility

Oversee regulatory and quality compliance activities across all facilities team operations and subcontractors
Prepare, review, and manage SOPs, quality investigations, deviations, CAPAs, and change control documentation
Interface with client quality organization to ensure adherence to all quality procedures and proper work documentation
Manage GxP contractor compliance programs including qualification, agreements, audits, and performance monitoring
Conduct quality audits and assessments of building systems such as HVAC, critical environments, and utilities
Collaborate with maintenance teams to support quality investigations and root cause analysis
Provide quality guidance and training to facilities staff, vendors, and service providers
Monitor and report on Key Performance Indicators and Service Level Agreement compliance
Review and approve technical documentation and quality reports for client delivery
Support continuous improvement initiatives and quality system enhancements

What we offer

401(k) plan with matching company contributions
Comprehensive Medical, Dental & Vision Care
Paid parental leave at 100% of salary
Paid Time Off and Company Holidays
Early access to earned wages through Daily Pay

Fulltime

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

Sr. QA Specialist - Ops

The Sr. QA Specialist – External Operations will work with other departments to ...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

7-9 years of pharmaceutical or biotech industry
4+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production
Bachelor’s Degree in a relevant scientific discipline preferred
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
Ability to Travel 10%

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
Responsible for tracking investigations and change control for timely completion. Provide status reports, including relevant quality metrics and participates in the management review process

Fulltime

Sr. QA Specialist - Ops

The Sr. QA Specialist – Team Lead will work with other departments to ensure the...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

7-9 years of pharmaceutical or biotech industry
4+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production
Bachelor’s Degree in a relevant scientific discipline preferred
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
Ability to Travel 10%

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
Responsible for tracking investigations and change control for timely completion. Provide status reports, including relevant quality metrics and participate in the management review process

Fulltime

New

Quality Associate II

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Medina

Salary:

76000.00 - 104500.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s of Science in a science related field is required
2+ years’ experience in quality with a medical device/pharmaceutical company or similar regulated industry, preferred
Working knowledge of Quality Systems and related requirements and standards, including 21 CFR Part 820, ISO 13485, preferred
Strong knowledge of risk management, root cause analysis, corrective and preventive action and document control
Demonstrated use of quality and root cause analysis tools, principles, and methodologies including statistical tools
Be able to author procedures in response to corrections or corrective actions
Have computer proficiency with experience in Microsoft Word, Excel, and Access or other database programs
This role requires extensive personnel interaction, including all functions and all levels of the organization
Must have computer proficiency
Ability to work effectively as part of a cross functional team

Job Responsibility

Own / Approve various Quality System Records
Responsible for conducting nonconformance root cause investigation, containment, correction, Field Action, corrective/preventive action, verification of effectiveness and closure activities
Identify, implement, and monitor process improvements to ensure continuous improvement to product and process quality
Mentor/coach Investigation Owners in developing investigation plan and results
Monitor Quality System related activities to ensure timeliness of completion
Verify respective functional activities for Quality System records are complete
Compile & present information to facility (Medina Plant) and external (i.e. Medina Design Center) CAPA Review Board. Maintain CRB information per established requirements, as needed
Develop and provide training as needed. Assist with Quality System Account Request Management
Generate weekly nonconformance reports, as needed
Participate in Audit readiness activities. Assist with / participate in Internal Audits, Corporate Audits, External Audits, as needed

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
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)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Quality Investigator

Aspire of WNY

Location:
United States , Getzville, NY

Category:
Quality Control

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
March 21, 2026

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