Quality Control Analyst II/Data Reviewer - NY

Company: Curia
Location: Amityville
Posted on: March 20, 2023

Job Description:

Quality Control Analyst II/Data Reviewer

The Quality Control Data Reviewer II is responsible for supporting the Stability & Reference Standard department and external customers. The principal responsibility of this role is the review and approval of primary analytical data according to cGMP guidelines. The QC Data Reviewer will be expected to review analytical data including HPLC, KF, USP testing for compliance and completeness against established SOPs, methods and procedures. This position will also support QA initiatives when necessary and collaborate with laboratory personnel to review data per cGMP compliance and data integrity. The Reviewer should incorporate sound judgement, critical thinking, and cGMP principles to ensure the integrity of the data meet acceptable quality standards. In addition, the Reviewer will provide appropriate guidance to analysts, supervisors, and quality personnel to promote compliance for our customers.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Supervisory responsibilities

This position does not have supervisory responsibilities.

Essential job duties

• Utilize various analytical instrumentation including but not limited to Gas Chromatography (GC), high-performance liquid chromatography (HPLC/UHPLC), ICP-MS, Infrared spectroscopy (IR), Differential scanning calorimeter (DSC), UV-Vis, Karl-Fischer auto titrator, Optical rotation, Dissolution, etc.
  
• Assist in technical data review of the raw data generated for various compendial testing (such as USP/NF, EP, JP, etc.) as well as Curia In-house and client methodologies for various client projects to ensure data accuracy and integrity
  
• Trend stability data to ensure consistency with historical timepoints and no unexpected results
  
• Verify calculations associated with Stability samples/Reference standards/Raw Materials/Intermediates testing are correctly done
  
• Format and review Stability summary tables, Stability Protocols for accuracy and compliance with current Curia formats
  
• Enter data into Stability summary tables. Perform tracking and trending of data as requested. Compile data and provide data summaries to management
  
• Collaborate with lab personnel for data review per cGMP compliance, data integrity
  
• Ensure all tests are per cGMP compliance and in compliance with the company's standard operating procedures
  
• Provide support on QA initiatives (Investigations, change controls etc.) when necessary
  
• Review and approve test methods, SOPs, forms, and other documents as necessary
  
• Interact with outside departments including attending meetings, providing updates, etc.
  
• Coordinate testing performed at contract testing labs for stability samples etc.
  
• Provide training to new hires as needed. Attend internal and external training on related subjects, cGMP compliance and data integrity, new techniques and procedures
  
  Education, experience, certification and licensures
  
  Required
  
• Bachelor's Degree in Natural Science, Pharmacy or equivalent
  
• Minimum 3-5 years' relevant industrial experience
  
  Preferred
  
• Experience working in cGMP or GLP pharmaceutical industry environment
  
  Knowledge, skills and abilities
  
• Chemical Hygiene training
  
• Working knowledge and understanding of various analytical instrumentation including but not limited to Gas Chromatography (GC), High-performance liquid chromatography (HPLC/UHPLC), ICP-MS, Infrared spectroscopy (IR), Differential scanning calorimeter (DSC), UV-Vis, Karl-Fischer auto titrator, Optical rotation, Dissolution, etc.
  
• Understand and interpret complex analytical techniques such as Method Validation, Method Transfer, Method Verification, Stability testing methodologies
  
• Excellent verbal and written communication skills, including the ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
  
• Ability to meet deadlines and work under pressure with limited supervision
  
• Strong time management and organizational skills with the ability to multi-task and manage multiple projects independently
  
• Ability to apply mathematical concepts, operations and tasks
  
• Ability to define problems, collect data, establish facts, and draw valid conclusions
  
• Proficient in Microsoft Office Suite and instrument manufacture-based systems
  
• Knowledgeable in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485
  
  Physical requirements
  
  The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  
  While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to sit; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
  
  Work environment
  
  The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  
  While performing the duties of this Job, the employee is frequently exposed to fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; risk of electrical shock; explosives; risk of radiation and vibration. The noise level in the work environment is usually moderate.
  
  The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel as classified. Management reserves the right to revise or amend duties at any time.
  
  All interested applicants must apply online. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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Keywords: Curia, New Haven , Quality Control Analyst II/Data Reviewer - NY, Professions , Amityville, Connecticut