Specialist Data Reviewer Jobs

Interpersonal skills to lead and train less experienced QC staff

8+ years’ experience as a QC chemist/analyst.

Review quality data and reports (including stability and release) for compliance against specifications, GMP regulations, and scientific technique.

Author’s stability reports, COAs, data summaries, Standard Operation Procedures, deviation and OOS investigation reports as needed.

Provide training and guidance to other analysts

BS/MS in chemistry, biology or related discipline

You have effective time management skills

You have excellent attention to detail and critical thinking skills

You have basic working knowledge of Microsoft Suite (Word, Excel, Powerpoint)

You have strong interpersonal skills

You have excellent written and verbal communication skills

Documenting in real time all GMP activities performed

Knowledge of Quality Management Systems and LIMS systems

Experience with MS Programs such as Word, Excel, PowerPoint, Access, Project etc. and Proofreading skills

Ability to manage multiple priorities and re-prioritize tasks as required. Excellent problem-solving skills

Understand and adhere to the Quality System requirements.

Apply extensive technical expertise and knowledge of related disciplines/processes.

Strong technical knowledge of various analytical equipment, techniques, and methodology.

B.S. or M.S. degree with at least 2-5 years relevant experience.

Working experience in a cGMP environment is preferred.

On-site near Billerica, MA area

6-12 month contract to extend or convert

Monitor, compile, and review analytical and QC data

Assist team with coordination of sample pulls, set downs, and tracking critical reagents.

Experience communicating effectively to management.

To take on any other duties which are within the employee’s skills and abilities whenever reasonably instructed.

Knowledge and previous experience with GMP, ICH Q7, and 21 CFR Part 11.

Develop technical proficiency, think independently, exercise sound judgments that correspond with experience, and adhere to safe work practices.

BS in Analytical Chemistry or equivalent with 5-7 years related experience in a pharmaceutical industry.

MS in Analytical Chemistry or equivalent with 3-5 years related experience in a pharmaceutical industry.

Knowledge of Quality Management Systems

Experience with MS Programs such as Word, Excel, PowerPoint, Access, Project etc. and Proofreading skills

Ability to manage multiple priorities and re-prioritize tasks as required. Excellent problem-solving skills

Data Review of Raw Material, Release and In-Process testing, Stability, Cleaning Verification samples, Microbiological testing, and Analytical test method Development/Qualification/Verification/Transfer/Validation

Strong technical knowledge of various analytical equipment, techniques, and methodology

Lead and organize QC Analysts and Lab Technicians as well as interface with managers of other departments as needed.

Experience with a LIMS (Laboratory Information Management System) system and Empower.

Strong self-management and organizational skills.

Strong understanding of FDA guidelines, Compendial and cGMP requirements.

Trackwise experience (change controls, Investigations, Activity Planning).

Laboratory experience with HPLC and CE instruments and Testing.

Previous experience testing by compendia methods.

Proficiency in LIMS and Quality Management software packages

Knowledge and/or extensive knowledge of GxP regulations

Two-Four (2-4) years’ experience performing data review in a GxP environment

Experience with relevant bioanalytical methods such as immunoassays, cell-based assays, or qPCR

Identify deviations, OOS and OOT associated with Bioanalytical Operations data as applicable

Issue QC review observations and work closely with the scientific staff to ensure data integrity

Proficiency in LIMS and Quality Management software packages

Knowledge and/or extensive knowledge of GxP regulations

Two-Four (2-4) years’ experience performing data review in a GxP environment

Experience with relevant bioanalytical methods such as immunoassays, cell-based assays, or qPCR

Identify deviations, OOS and OOT associated with Bioanalytical Operations data as applicable

Issue QC review observations and work closely with the scientific staff to ensure data integrity

Experience in Google Doc applications (Docs, Sheets, Forms) or willingness to take a Udemy course to develop the required skills,

Love for kids and interest to play kid games (preferably five years' experience with kids),

Have a graduate degree (3 or over) from the top ten universities in your country,

Have proficiency in written and verbal communication in English,

Attention to detail when implementing written guidelines such as downloading games from Apple Store, filling out a Google Form etc.,

Able to adapt to teamwork.

Vacation, sick time and holidays

Volunteer time to participate within your community

Paid sabbatical after 5 years; every 3 years thereafter

Here’s What You’ll Bring to the Table:

Generous paid time off, including: