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American Regent, Inc. · 1 month ago

QA Specialist - Deviations

Shirley, NY

Full-time

Onsite

Mid, Senior Level

$80K/yr - $85K/yr

2+ years exp

American Regent, Inc. is a company focused on the manufacturing of sterile pharmaceuticals. The QA Specialist - Deviations is responsible for investigating and documenting non-routine events in compliance with company SOPs and cGMPs, while also ensuring quality system compliance and facilitating investigations across departments.

Health CareMedical

H1B Sponsor Likely

Responsibilities

Ensures any non-routine events associated with the manufacture of safe, pure, and effective sterile pharmaceuticals are investigated and documented in accordance with company SOPs, policies and cGMPs and within assigned timelines

Identify trends, evaluate metrics, and provide support for internal audits under the direction of the QA Deviations Supervisor

Ensure deviation timelines are maintained through inter-department communication

Facilitate and lead assigned investigations involving multiple investigation areas

Facilitate and participate in initiatives to address compliance gaps identified during investigations with minimal assistance

Provide quality system level assessments and reviews, author and facilitate change requests

Initiate and complete or assign investigations and CAPAs related to Quality departments (Quality Operations, Quality Control, Quality Systems)

Perform and guide root-cause analysis for events utilizing investigation tools (e.g., 5 whys, 6M, Fishbone Diagrams)

Perform the QA review and final approval signature for assigned deviations/events, confirming the completeness, accuracy, and consistency of all work so that it meets the standards of quality

Identify errors and inconsistencies and initiate resolution to ensure high quality

Coordinate/provide oversight for the investigations system, including follow up with cross-functional stakeholders (assignees, internal customers, reviewers, and approvers)

Act as a liaison between Operations and Quality in all matters related to investigations and CAPA

Under supervision assist with documentation for the closure of complaint investigations

Gather data for reports, metrics, Annual Product reviews and external requests

Generate and analyze metrics as assigned, employing statistical techniques as appropriate

Scheduling departmental meetings, maintaining meeting minutes and attendance

Maintain departmental records and files (both electronic and manual)

Participate in cross-functional project teams as required

Support, coordinate, and assist with regulatory agency audits and inspections as required

Support and maintain quality programs, policies, processes, procedures, and controls ensuring compliance with current Good Manufacturing Practices (cGMP)

Keep training curriculum current in ISO train

Ensure all work is performed and documented in accordance with existing company policies and procedures

Perform any other tasks/duties as assigned by management

Qualification

CGMP complianceQuality Assurance principlesRoot-cause analysisASQ CertificationStatistical quality managementQuality software knowledgePC SkillsEnglish proficiencyAttention to detailInterpersonal skillsCommunication skillsCritical thinkingOrganizational skillsCollaborative environment

Required

Bachelor's degree in a science or engineering field, or in lieu of a bachelor's degree, 8 years' experience in QA/QC in regulated environment

Minimum of 2-5 years of experience working in a Quality role within a cGMP manufacturing environment

Knowledge and understanding of quality assurance principles, controls, and interactions between Quality Systems; FDA guidance, ICH, PIC/S, etc

Strong attention to detail, adherence to SOPs

Ability to work effectively in a collaborative environment

Ability to effectively work under dynamic constraints, with success in managing multiple activities concurrently and producing outstanding results

Strong organizational, interpersonal and communication skills (oral and written). Written skills must be audit-level appropriate for non-routine or complex issues

Ability to apply critical thinking to scientific problems and demonstrated knowledge

Ability to apply statistical quality management concepts

PC Skills Required (MS Word, Excel). Preference will be given to candidates with demonstrated knowledge of Quality software such as TrackWise, Veeva and Minitab

Excellent English communication skills, both oral and written, and comprehension are required. Ability to effectively present information to top management, employees, or customers

Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves

Preferred

ASQ Certification as a Quality Engineer or Six Sigma Black belt

Benefits

Healthcare

Life insurance

Profit sharing

Paid time off

Matching 401k

A wide range of other benefits

Company

American Regent, Inc.

American Regent, Inc, a Daiichi Sankyo Group Company, develops, manufactures, and supplies high quality sterile injectables for healthcare providers, clinics and hospitals across the United States and Canada.

Founded in 1967

Shirley, New York, USA

501-1000 employees

http://www.americanregent.com/

H1B Sponsorship

American Regent, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (6)

2024 (10)

2023 (4)

2022 (5)

2021 (8)

2020 (9)