Quality Assurance Analyst

Job Title: QA Analyst II

FLSA Classification: Professional, Exempt

Work Location: Fall River, MA

Work Hours: General: 8:30AM – 5:00PM (may vary based on business needs)

*Only US Citizen or Green Card holder required*

Purpose

This position requires a strong analytical chemistry/lab background and experience. The job duties for this position include but are not limited to the following:

The Analytical Quality Assurance (AQA) associates II Or III position is a team or individual contributor role and reports to the Supervisor Analytical Quality Assurance.

The job duties for this position include but are not limited to the following:

• Reviewing and confirming the compliance related to raw materials, in process and finished product analytical documents.
• Monitoring and ensuring of current Good Laboratory Practices (cGLP) followed by laboratory personnel during routine operation to ensure adherence to procedure.
• Confirming and ensuring compliance of the protocols and reports of method validations / verifications / comparison reports and any other study reports.
• Prepare and review laboratory investigation (OOS/OOT/Deviation) reports and ensure compliance of same.
• Verifying the laboratory chemicals/reagents, standards for completeness of the labels against standard operating procedures (SOPs).
• Assessing and implementing Pharmacopoeia changes whenever any new edition, supplement, amendment, or other changes of any Pharmacopoeia are in effect.
• Review of laboratory audit trials during data review against standard operating procedures (SOPs).
• Coordinating with the Analytical Laboratory Teams to arrange required documents to cross functional teams.
• Maintaining all the incoming documents with proper tracking, recording, storage and archival of the documents.
• Reviewing and identifying the gaps within the system during routine monitoring and informing the supervisor of necessary improvements in the identified areas.
• Actively participating in review of data related to laboratory investigations and incidents and ensuring proper compliance.
• Performing other departmental and cross-functional projects and assignments given by the manager/supervisor.

Education And Experience

• Possess a minimum bachelor’s degree in chemistry, Pharmaceutical Sciences, or related field of study from an accredited institution. Master’s degree in the above and/or related fields of study as noted above preferred.
• A minimum of 4-8 years in analytical (preferably in analytical quality assurance for minimum of 3 years).
• Must be proficient in computer skills and software applications such as Microsoft Office tools and Quality applications and software programs.
• Strong knowledge and experience with analytical laboratory activities in areas such as active pharmaceutical ingredients (API), drug products, analytical development, Quality Control (QC), Good Laboratory Practices (GLP)/Good Manufacturing Practices (GMP)/Good documentation Practices (GDP), USP monograph requirements.

Technical Knowledge and Computer Systems Skills

• Understanding of laboratory equipment operation, qualification and calibrations which includes their software audit trial reviews. E.g. HPLC, UV Vis Spectrophotometer, GC, Potentiometer, pH meter, Stability chambers, etc.
• Strong knowledge on USP monograph requirements, FDA & ICH guidance requirements, etc.
• Effective interpersonal relationship skills and the ability to work in a team environment.
• Experience in Inhalation products (MDI/DPI) is a plus.
• Ability to work in a fast-paced, dynamic environment within a manufacturing operation setting.
• Must be able to communicate clearly and concisely across all levels of the organization and possess a solid command of English language communication skills verbally, written, and interpersonally.
• Must possess strong documentation and technical writing skills, and able to apply relevant scientific principles and practices.
• Must be able to work under minimal supervision and able to work independently and in a team environment.

Professional and Behavioral Competencies

• Proficiently speak English as a first or second language and ability to read, write and communicate effectively the same.
• Must be a self-starter and demonstrate initiative to seek additional training or direction as needed.
• Must be willing and able to work any assigned shift ranging from first or second shift; work schedules may be Monday to Friday.
• Knowledge of good manufacturing practices and good documentation practices preferred.
• Self-motivated, with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously.
• Excellent organizational skills with the ability to focus on details.

Work Schedule and Other Position Information

• General shift but must be willing and able to work any assigned first or second shift. Work schedule may be Monday to Friday, Tuesday to Saturday, or some combination thereof based on business needs.
• Must be willing to work some weekends based on business needs as required by management.
• Relocation negotiable.
• No remote work available.
• This role works in cGMP laboratory or manufacturing environment, where personal protective equipment (PPEs) is required, which may include uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection, etc.
• The role may be assigned on a work-shift basis where required (Day, Evening, Night). Weekend or Holiday work may be requested or required based on business needs.