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Post : Senior Quality Assurance (QA) Specialist - Analytical QA
Job Description
Sourcing Guidelines
• Must have a strong background in QC/analytical lab and manufacturing.
• No employment sponsorship.
• Immediate availability is preferred.
• Urgent need to fill this position.
The Quality Assurance (QA) Senior Analyst position is an individual contributor role and reports to the Senior Manager of Analytical QA for the client. The job duties for this position include but are not limited to the following:
• Confirming and ensuring the compliance of the protocols and reports of method validations / verifications / comparison reports and any other study reports.
• Monitoring and ensuring of current Good Laboratory Practices (cGLP) followed by laboratory personnel during routine operation to ensure adherence to procedure.
• Verifying the standard operating procedures (SOPs) and test procedures.
• Verifying process validation and characterization-related documents.
• Coordinating with the Regulatory Affairs (RA) and Analytical Laboratory Teams to arrange required documents for timely submission as part of new and existing abbreviated new drug applications (ANDAs).
• 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 for necessary improvements in the identified areas.
• Actively participating in laboratory investigations and incidents as well as ensuring the proper compliance.
• Evaluating and confirming the compliance related to raw materials, in-¬process and finished product analytical documents.
• Conducting random internal audits in analytical lab and ensuring the compliance.
• Assessing and implementing of Pharmacopoeia changes whenever any new edition, supplement, amendment, or other changes of any Pharmacopoeia are in effect.
• Performing other departmental and cross-functional projects and assignments given by the manager.
Candidate Profile
• Possess a 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 eight (8) years of relevant work experience in a pharmaceutical manufacturing setting within the Quality function.
• Experience using statistical software packages is a plus.
• Must be proficient in computer skills and software applications such as Microsoft Office tools and Quality applications and software programs.
• Current, working knowledge of quality assurance (QA).
• 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 Distribution Practices (GDP), etc.
Other Job Information
• Relocation negotiable.
• No employment sponsorship.
• No remote work available.
• Must be willing to work some weekends based on a relevant business need, if required.
Additional Information
Experience : 8 - 10 Years
Annual Salary : $55,000.00-$80,000.00 USD
Work Location : Central Islip, New York, USA
Domain : Pharmaceuticals / Biotechnology / Clinical Research
Mobile Number : 9341636400
Email : kld@inspireconsultancy.com
Posted by
Kamalesh Dumawat
Inspire Consultancy Services
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