Quality Control Data Integrity Specialist Job at Stira Pharmaceuticals, Fairfield, Essex County, NJ

TEEvQWJxcVZsNTMvMnZSbHFOc3RJRGprQUE9PQ==
  • Stira Pharmaceuticals
  • Fairfield, Essex County, NJ

Job Description

Job Description

Company Description

Stira Pharmaceuticals is a sterile injectable CDMO based in Fairfield, NJ. We specialize in pharmaceutical product development and manufacturing of small molecules and peptides. Our services span Analytical R&D, Formulation Development, Regulatory Support, and more. Backed by a team of highly skilled scientists, Stira brings deep technical expertise and a proven track record in developing complex and challenging products.

Role Description

Stira Pharmaceuticals is seeking a meticulous and experienced Quality Control Data Integrity Specialist to join our Quality Control team in Fairfield, NJ. This full-time, on-site role is responsible for safeguarding the integrity, accuracy, and compliance of data generated from QC testing. The successful candidate will play a critical role in ensuring that all QC documentation meets Good Manufacturing Practice (GMP) requirements and regulatory expectations, with a particular focus on cross-validation using orthogonal analytical techniques.

Key Responsibilities

  • Review raw QC data for completeness, accuracy, and compliance with GMP and regulatory standards.
  • Verify that QC test methods and protocols are consistently followed and align with approved specifications.
  • Ensure data integrity for results generated from advanced analytical platforms, including HPLC, GC, FTIR, UV-Vis, LC/HRMS, ICP-MS, and other orthogonal techniques.
  • Critically evaluate data by confirming results through orthogonal testing approaches, ensuring robustness and reliability of conclusions.
  • Identify, document, and resolve discrepancies, deviations, or errors in QC records; collaborate with laboratory staff to implement corrective and preventive actions.
  • Ensure accuracy and completeness of QC documentation, including laboratory notebooks, instrument logs, and certificates of analysis.
  • Partner with Quality Assurance and Regulatory Affairs to uphold data integrity and compliance across submissions and inspections.
  • Review and approve QC documentation to support material and product release.
  • Support internal audits and regulatory inspections by maintaining ready access to accurate QC records.
  • Provide training and guidance to QC staff on data integrity principles, documentation practices, orthogonal method utilization, and regulatory compliance.
  • Stay current with evolving regulations, industry guidance, and best practices in QC data integrity and orthogonal testing.

Qualifications

  • Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
  • Minimum 3 years of QC data review or data integrity experience within the pharmaceutical or biotechnology industry.
  • Strong knowledge of GMP, GLP, and applicable global regulatory requirements.
  • Hands-on experience with QC analytical techniques such as HPLC, GC, FTIR, UV-Vis, L C/HRMS, ICP-MS, and other orthogonal technologies.
  • Demonstrated ability to apply orthogonal techniques for data confirmation and cross-validation.
  • Exceptional attention to detail with a strong focus on data accuracy and integrity.
  • Strong organizational and time management skills; able to manage multiple priorities effectively.
  • Excellent communication and interpersonal skills for cross-functional collaboration.
  • Proficiency with Laboratory Information Management Systems (LIMS) and electronic data systems preferred.
  • Familiarity with regulatory submissions (ANDA, IND, NDA) is a plus.

Job Tags

Full time,

Similar Jobs

Children's Hospital Los Angeles

Psychiatric Social Worker II / Department of Psychology / Full-time / Days Job at Children's Hospital Los Angeles

 ...** Master's Degree in Social Work, Marriage & Family Therapy, Psychology, Counseling with previous experience in a child, adolescent, or...  ...Act. Please contact CHLA Human Resources if you need assistance completing the application process.Our various experiences, perspectives... 

Fayetteville Technical Community College

POOL - Online Medical Transcription & Editing Instructor (Continuing Education) (Part-time) Job at Fayetteville Technical Community College

 ...criminal background check. First Section Pool Title POOL - Online Medical Transcription & Editing Instructor (Continuing...  ...Qualifications Online instructors must provide documentation of online teaching experience. Full or Part Time Part Time Special... 

Dorel Juvenile

Sr. Fashion Designer Job at Dorel Juvenile

 ...As the Sr. Fashion Designer in this role, you will apply your design skills to create original, innovative design proposals that appropriately reflect our Brands. Through continued research, consumer insight, and trend evaluation, you will help to identify key trends... 

My City Transportation

Class A Truck Driver (Home Daily) Job at My City Transportation

 ...Dedicated Class A Truck Drivers needed for immediate hire! Position Information: Home every day. No Touch freight. No idle on the road time. BOTH Day/Night Shift. Runs to Atlanta, Birmingham, south GA. Pay Information: ~ Averaging 1300+ a week... 

Adept Consulting Services, Inc.

Senior Nexus Network Engineer Job at Adept Consulting Services, Inc.

 ...As a Network Engineer on this project, you'll help design, set up, and support new network solutions. You'll work with Cisco and Nexus technologies, troubleshoot issues, and make sure new equipment works smoothly with the current system. This role requires good technical...