Senior Quality Assurance Specialist - Analytical QA - Pharmaceuticals/Biotechnology/Clinical Research

Senior Quality Assurance Specialist - Analytical QA - Pharmaceuticals/Biotechnology/Clinical Research

Senior Quality Assurance (QA) Specialist - Analytical QA

Pharmaceuticals/Biotechnology/Clinical Research

Central Islip, New York, USA

Client Details : CARING FOR LIFE

Global Company Info :

- The client is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies.

- Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world.

- The client employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees, who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Client's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.

- Client, also known as Client New York, is engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with a focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. As of February 18, 2016, Client. operates as a subsidiary of Client (EU) Limited.

Job Details :

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

Payment Terms

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.

GENERAL POSITION OVERVIEW :

- The Quality Assurance (QA) Senior Analyst position is an individual contributor role and reports to the Senior Manager of Analytical QA for Client., a Client subsidiary (also known as Client New York). 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 current Good Laboratory Practices (GLP) followed by laboratory personnel during a 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 proper compliance.

- Evaluating and confirming the compliance related to raw materials, in-process and finished product analytical documents.

- Conducting random internal audits in an analytical lab and ensuring 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.

PROFESSIONAL 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 is negotiable.

- No employment sponsorship.

- No remote work available.

- Must be willing to work some weekends based on a relevant business need, if required.