Sr Data Reviewer I

Bora Pharmaceuticals•Maple Grove, MN

1d•$74,000 - $95,000•Onsite

About The Position

Bora Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products. From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide. At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain. The Sr. Data Reviewer I is responsible for auditing analytical testing documentation to ensure testing is completed according to appropriate test methods and standard operating procedures. Provides leadership and technical expertise in response to investigations and/or production issues. Conducts evaluations of historical testing data and validation work as required. Has an expert level understanding of GMP documentation requirements and ensures documentation and auditing practices in QC comply with industry requirements.

Requirements

A Bachelor's Degree in Chemistry or related science field with a minimum of 6 years of related experience, preferably in the pharmaceutical industry.
Analytical chemistry knowledge is required.
Experience working in a laboratory environment, preferably in the pharmaceutical industry.
Strong verbal and written communication skills are required, as well as the ability to work independently and within the framework of a team environment.
Two years of data review experience preferred
Ability to effectively multi-task.
Experience or training using Microsoft Word and Excel and other computer software (SAP, EDMS).

Nice To Haves

Proficient with USP/NF general chapters and reviews monograph testing with minimal support.
Has a strong understanding of the theory behind general laboratory instruments.
Has an expert-level understanding of GMP documentation requirements and ensures documentation and auditing practices in QC comply with industry requirements.
Updates procedures (training documents, SOPs, etc) as necessary.
Evaluates lab systems and processes.
Provides recommendations for efficiency improvements and cost savings.
Responsible for communicating with outside vendors/laboratories.
Proficient with laboratory and administrative software (e.g. Empower, SAP, EDMS, electronic laboratory notebook (Biovia)).
Authors justifications for regulatory documents, APQR reports, and impact assessments with support.
Develops a basic understanding of statistical analysis and data trending.
Reviews data against criteria specified by basic method validation/verification protocols (e.g. method comparisons, transfers, solution stability establishment, etc.).
Monitors the collective data review group workload.
Reviews the highest-priority samples first and completes review in a timely manner.
Notifies management if deadlines will not be met.
Independently tracks testing/review of high priority batches.
Provides support and input to junior data reviewers to help ensure the group meets product due dates.
Trains junior data reviewers on advanced documentation/data review.
Reviews laboratory investigation reports.
Has a firm understanding of internal documents (SOPs and test methods) and industry guidance's (FDA, ICH).
Provides training to others as necessary.
Revise test methods and SOPs as necessary.
Provides training in documentation in accordance with cGMPs, SOPs, and industry trends.
Offer leadership and technical expertise in response to problems, such as Product investigations, analytical issues, and/or production problems.
Demonstrates an understanding of applicable regulations and guidance's (e.g., DEA, EPA, OSHA and FDA).
Serves as a subject matter expect for documentation interpretation.
Aids in preparing documents for regulatory submissions.
Tracks the due dates on the laboratory schedule to ensure the entire data review team is able to meet the necessary timelines.
Works with others in a general laboratory environment.
Routinely handles chemicals.
Required to wear safety glasses and a lab coat while in the lab area.
May be required to wear other protective equipment such as goggles, gloves, ear protection, etc.

Responsibilities

Responsible for reviewing analytical testing documentation to ensure project and production timelines are met.
Ensures all testing is conducted according to appropriate test methods and standard operating procedures.
Verifies that all calculations are correct and ensure that final reported testing results are accurate.
Confirms that all equipment used for testing has been calibrated.
Ensures all appropriate documentation for the equipment used was complete appropriately.
Verifies that all reagents, standards, test solutions, and volumetric solutions used for testing were prepared correctly and used within their respective expiries.
Reviews all testing performed by USL’s QC laboratory, including FTIR, UV/VIS, HPLC, GC, ICP-MS, etc.
Keeps abreast of new testing techniques and technologies across industry.
Responsible for identifying and communicating errors found in testing documentation.
Work to quickly resolve any required corrections with the appropriate laboratory personnel.
Accountable for communicating atypical and out-of-specification results to laboratory management.
Communicates complex questions or corrections effectively with analysts/team members/management within QC and method development department.
Collaborates cross-functionally to evaluate historical data and support process improvements.
Enters and verifies analytical results in SAP.
Releases analytical results in SAP, which includes verification of expiration dating and critical vendor information.
Proficient with USP/NF general chapters and reviews monograph testing with minimal support.
Has a strong understanding of the theory behind general laboratory instruments.
Has an expert-level understanding of GMP documentation requirements and ensures documentation and auditing practices in QC comply with industry requirements.
Updates procedures (training documents, SOPs, etc) as necessary.
Evaluates lab systems and processes.
Provides recommendations for efficiency improvements and cost savings.
Responsible for communicating with outside vendors/laboratories.
Proficient with laboratory and administrative software (e.g. Empower, SAP, EDMS, electronic laboratory notebook (Biovia)).
Authors justifications for regulatory documents, APQR reports, and impact assessments with support.
Develops a basic understanding of statistical analysis and data trending.
Reviews data against criteria specified by basic method validation/verification protocols (e.g. method comparisons, transfers, solution stability establishment, etc.).
Monitors the collective data review group workload.
Reviews the highest-priority samples first and completes review in a timely manner.
Notifies management if deadlines will not be met.
Independently tracks testing/review of high priority batches.
Provides support and input to junior data reviewers to help ensure the group meets product due dates.
Trains junior data reviewers on advanced documentation/data review.
Reviews laboratory investigation reports.
Has a firm understanding of internal documents (SOPs and test methods) and industry guidance's (FDA, ICH).
Provides training to others as necessary.
Revise test methods and SOPs as necessary.
Provides training in documentation in accordance with cGMPs, SOPs, and industry trends.
Offer leadership and technical expertise in response to problems, such as Product investigations, analytical issues, and/or production problems.
Demonstrates an understanding of applicable regulations and guidance's (e.g., DEA, EPA, OSHA and FDA).
Serves as a subject matter expect for documentation interpretation.
Aids in preparing documents for regulatory submissions.
Tracks the due dates on the laboratory schedule to ensure the entire data review team is able to meet the necessary timelines.
Works with others in a general laboratory environment.
Routinely handles chemicals.
Required to wear safety glasses and a lab coat while in the lab area.
May be required to wear other protective equipment such as goggles, gloves, ear protection, etc.