Quality Assurance Engineer

Aveva Drug Delivery Systems; Town of Florida (NY); On-site; USD 110,000 - 140,000; Full time

Job summary

Aveva Drug Delivery Systems in the United States (New York area) seeks a Compliance Subject Matter Expert for Production Operations. You will support incident/deviation investigations, generate and update production documentation, and provide QA support across disciplines to ensure cGMP compliance and regulatory commitments.

The role requires multi-tasking, cross‑functional collaboration with Technical Services, Engineering, Quality Control and Production, plus strong documentation and

Qualifications

• Knowledge of GMPs (21CFR Parts 210 and 211).
• Ability to prepare/edit pharmaceutical documentation (batch records, SOPs, protocols).
• Understanding of FDA/Health Canada regulations and good documentation practices.

Responsibilities

• Review and approve investigations for product quality deviations.
• Review validation and qualification documents.
• Lead investigation teams to assess impact on product quality and validation status.
• Monitor CAPAs and implement process improvements in manufacturing.
• Ensure compliance with GMPs and company policies; mentor colleagues.

Skills

GMP knowledge

Analytical data

Documentation editing

Regulatory knowledge

Root-cause analysis

Specifications & SOPs

English writing

Project management

Education

Bachelor's degree in Engineering or Life Sciences

Master’s degree in related field (cGMP)

Bachelor’s in Chemistry or related field (preferred)

Tools

HPLC

GC

UV-VIS

Dissolution

pH measurement

Titration

Job description

About Us:
Aveva Drug Delivery Systems is a pharmaceutical manufacturer at the forefront of innovative drug delivery technologies. We are dedicated to advancing solutions that optimize the efficacy, safety, and precision of pharmaceutical treatments. Join our team and help shape the future of healthcare by contributing to the development of groundbreaking drug delivery systems that improve patient outcomes worldwide.

Description
About Us:
Aveva Drug Delivery Systems is a pharmaceutical manufacturer at the forefront of innovative drug delivery technologies. We are dedicated to advancing solutions that optimize the efficacy, safety, and precision of pharmaceutical treatments. Join our team and help shape the future of healthcare by contributing to the development of groundbreaking drug delivery systems that improve patient outcomes worldwide.
Job Summary
Become the subject Matter expert for Compliance as related to Production Operations. Responsible for assisting personnel with the completion of Incident / Deviation investigation process as well as the generation and or updating of pertinent Production related documentation. Provide Quality Assurance support to stake holders from various departments to assist with completion of such tasks as validations, qualifications, documentation updates, investigations, and projects. Working with Production, perform initial assessment to determine if a production line may or may not resume production after the identification of an event.
The position requires the ability to multi-task, meet timelines, and maintain cross-functional interactions with key stake holders (Technical Services, Engineering, Quality Control and Production).
The position may involve the review and approval of validation of analytical methodology (protocols and reports), specifications, master batch records, executed batch records, formulation spreadsheets and Standard Operating procedures (SOPs) in support of research projects involving pharmaceutical components and/or drug products ensuring compliance with cGMP's, company procedures and regulatory commitments.
Job Responsibilities

• Reviews and approves Investigations for product quality deviations.
• Reviews validation and qualification documents.
• Becomes Subject matter expert for company product line, production equipment, batch records and relevant SOP’s.
• Reviews and analyzes documents and data such as batch records, lab testing, finished product material statuses so as to support completion of the investigation process.
• Serves as an investigation team leader so as to assess impact on product quality and validation status.
• Recommends and monitors improvements in manufacturing and control systems including corrective and preventative actions (CAPA).
• Works together with multiple departments to troubleshoot the production processes and identify process improvement opportunities.
• Ensures compliance with GMP’s.
• Provides training and mentoring to colleagues performing investigations.
• Writes/revises SOPs relevant to the position’s responsibilities.
• Working with the Production Quality team, assess events when they arise to determine ability to resume production.
• Interpret specifications, standard operating procedures, and standard testing procedures.
• Responsible for the review and approval of validation of analytical methodology (protocols and reports), specifications, master batch records, formulation spreadsheets, and Standard Operating procedures (SOPs) in support of research projects involving pharmaceutical components and/or drug products components and/or drug products.
• Performs assessments / approvals of change controls related to production activities.
• Ensures compliance with all Company policies and procedures including safety rules and regulations.
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
• Performs all work in support of our Values: Innovate, Evolve, and Excel.
• All other relevant duties as assigned.
  

Qualifications
Education

• A Bachelor’s degree in Engineering or Life Sciences from an accredited college or university with a minimum of 5 - 8 years experience
• Master’s degree and 3-5 years of experience in a cGMP regulated manufacturing environment or an equivalent combination of training and experience is required.
• Preferred Bachelor’s degree (B.S.) in chemistry or related field with at least 5-8 years of experience in pharmaceutical analytical laboratory with transdermal laboratory experience, or Master’s degree (M.S.) with at least 3-5 years of experience.
  

Required Knowledge, Skills, And Abilities

• Knowledge of GMP’s (21CFR Parts 210 and 211)
• Analyzing and troubleshooting problems, identifying root causes and recommending and implementing effective methods, procedures, systems and/or techniques.
• Ability to prepare / edit all types of pharmaceutical documentation (batch records, SOPs, protocols, summary reports, etc.)
• Sound knowledge of the FDA, Health Canada, and other pharmaceutical regulations.
• Thorough understanding of GMPs, specifically those relating to good documentation practices.
• Ability to analyze and interpret analytical data.
• Interpret specifications, standard operating procedures, and standard testing procedures.
• Strong organizational skills
• Managing multiple projects, duties, and assignments.
• Writing and interaction in English.
  

Preferred Knowledge, Skills, And Abilities

• Knowledgeable in multiple instrumentation techniques such as HPLC, GC, UV-VIS, dissolution equipment, pH measurement, titration, etc.
• Knowledgeable in analytical testing of API, excipients and components following compendial and validated methods.
• Analytical chemistry and common instrumentation