Overview
Test Lead Engineer, Sr Jobs in Remote at TISTA Science and Technology Corporation
Role: Analytical QA Supervisor
Location: Fall River, MA
Work Hours: General shift (8:30 AM – 5:00 PM); may vary based on business needs
Employment Type: Full-time, On-site
Experience Required: 5 – 15 Years
Must Have: *Pharma Exp is mandatory (No Bio Pharma)
*An educational Chemistry Background is highly preferred,
*A strong work experience in a pharmaceutical manufacturing setting within the Quality function.
*Minimum of five (5) years’ experience in quality assurance in a cGMP pharmaceutical manufacturing operation environment.
*Current working knowledge of analytical quality assurance (AQA).
*Experience in Inhalation products (MDI) is a plus (Can also take candidates with liquid, solid, tablets, and capsules experience)
*Should be proficient in reading, writing, and speaking English
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* The resume should specify the candidate’s experience with MDI, liquid, solid, tablets, and capsules dosage experience.
Key Responsibilities:
Review and ensure compliance of method validations, verifications, and analytical study reports.
Monitor adherence to cGLP and laboratory procedures by lab personnel.
Verify standard operating procedures (SOPs) and analytical test methods.
Coordinate with Regulatory Affairs and Analytical Labs for timely submission of ANDA documents.
Manage incoming QA documents, ensuring proper tracking, storage, and archival.
Approve and review laboratory raw data, including audit trails.
Identify and report system gaps; support continuous improvement efforts.
Participate in lab investigations, audits, and incident management.
Evaluate raw materials, in-process, and finished product analytical documentation for compliance.
Conduct internal audits in the analytical lab.
Implement changes related to pharmacopoeial updates (USP/EP/JP).
Support cross-functional and departmental projects as needed.
Education & Experience Requirements:
Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or related field (Master’s preferred).
Minimum 8 years of relevant QA experience in pharmaceutical manufacturing (preferably 8–15 years).
At least 5 years of experience in a cGMP quality assurance environment.
Proficiency in MS Office and quality software applications.
Strong knowledge of analytical QA principles, GLP/GMP/GDP, and regulatory expectations.
Experience with laboratory instruments such as HPLC, GC, UV-VIS, pH meters, etc.
Familiarity with USP monographs and FDA/ICH guidelines.
Prior experience with inhalation products (MDI) is a plus.
Skills & Competencies:
Strong documentation and technical writing skills.
Ability to work independently and as part of a team.
Strong organizational skills and attention to detail.
Effective communication and interpersonal skills.
Capable of conducting investigations and root cause analyses.
Able to support internal and external audits.
Demonstrated initiative and ability to manage multiple priorities.
Fluent in English (spoken and written).
Additional Information:
On-site position (no remote work available).
Must be willing to work flexible hours including weekends or holidays as required.
PPE compliance required in laboratory/manufacturing environments.
Relocation assistance is negotiable.
Job Type: Full-time
Pay: $75,000.00 – $95,000.00 per year
Education:
Bachelor’s (Preferred)
Experience:
Analytical QA: 10 years (Required)
Pharmaceutical: 10 years (Required)
CGMP: 10 years (Required)
MDI: 10 years (Required)
Solid Dosage: 10 years (Required)
Liquid Dosage: 10 years (Required)
Tablet: 10 years (Required)
Capsule: 10 years (Required)
Chemistry: 5 years (Required)
Location:
Fall River, MA (Required)
Work Location: In person
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Title: Test Lead Engineer, Sr
Company: TISTA Science and Technology Corporation
Location: Remote
