NewJob: Urgent hiring Sr Quality Assurance (QA) Specialist - Analytical QA- ANALYTICAL CHEMISTRY/LAB/ Pharmaceuticals/ Biotechnology/ Clinical Research BACKGROUND, 5Posts, 8-10Yrs, 40-65LPA, No employment sponsorship, ONLY US citizens/ GC holders will be processed; New York USA Job Code: 3CINVAGENPH/SQA.ANACHEMI810Y55$80K/11132020

Dear Consultant,

 

Urgent hiring Senior Quality Assurance (QA) Specialist - Analytical QA- ANALYTICAL CHEMISTRY/LAB/ Pharmaceuticals/ Biotechnology/ Clinical Research BACKGROUND, 5Posts, 8-10Yrs, 40-65LPA, No employment sponsorship, ONLY US citizens/ GC holders will be processed; New York USA

 

Job Code: 3CINVAGENPH/SQA.ANACHEMI810Y55$80K/11132020

 

Job Details

Senior Quality Assurance (QA) Specialist - Analytical QA- ANALYTICAL CHEMISTRY/LAB/ Pharmaceuticals/Biotechnology/Clinical Research

Experience 8 - 10 Years

Work Location New York, USA

Domain Pharmaceuticals/Biotechnology/Clinical Research

 

Job Description

SOURCING GUIDELINES for RECRUITER

·         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 Specialist position is an individual contributor role and reports to the Senior Manager of Analytical QA

·         THIS POSITION REQUIRES A STRONG ANALYTICAL CHEMISTRY/LAB BACKGROUND AND EXPERIENCE.

·         Please DO NOT disclose salary details of the job role to the candidate over email or via social media. You may indicate salary being offered is as per industry standard

·         Please DO NOT post the job on any public forum

·         However you can ask for their Salary expectation

·         ONLY US citizens/ GC holders will be processed.

·         NO POACH agreement with Torrent Pharma and Cipla

 

GENERAL POSITION OVERVIEW

 

·         The Quality Assurance (QA) Senior Specialist position is an individual contributor role and reports to the Senior Manager of Analytical QA

·         THIS POSITION REQUIRES A STRONG ANALYTICAL CHEMISTRY/LAB BACKGROUND AND EXPERIENCE

• 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, in­process 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.

 PROFESSINAL COMPETENCIES AND TECHNICAL SKILLS

 

• 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.
• Must be able to exercise appropriate professional judgment on matters of significance.

EDUCATION AND EXPERIENCE

• 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.