What are the responsibilities and job description for the Data Reviewer position at PROMED MOLDED PRODUCTS INC?
As a ProMed employee, you will contribute to the manufacture of products that have a significant impact on people’s lives. Through honesty, integrity, and collaboration, we strive to be the very best as we hire the very best.
ProMed was founded in 1989 addressing an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We treat every component and finished device as though it will be used by a beloved family member or friend. We are dedicated to our customers and to our employees while helping to improve the health and well-being of people around the world.
Working as one to help many.
POSITION SUMMARY
The mission of this role is to safeguard product quality and regulatory compliance by executing rigorous data validation protocols that ensure all analytical testing results meet GMP standards before product release. This position serves as a critical quality gate, preventing costly regulatory violations and product recalls through comprehensive technical documentation review and data integrity assessments. By systematically identifying and resolving data discrepancies and anomalies, the role protects the organization's reputation and market access while maintaining the highest standards of scientific rigor. The position directly supports manufacturing operations and regulatory submissions by ensuring all data packages meet stringent compliance requirements, ultimately enabling successful product commercialization and sustained market presence. The Data Reviewer ensures ProMed’s brand, philosophy, systems, policies, and procedures are properly implemented and observed.
ESSENTIAL DUTIES & RESPONSIBILITIES
Position duties and responsibilities include, but are not limited to the following:
Review analytical testing data for accuracy and completeness to ensure all scientific results meet GMP compliance standards and regulatory requirements, enabling reliable product release decisions and successful regulatory submissions.
On average this should be about 85% of your time. Among other things this means we expect you to:
- Validate instrument calibration status prior to accepting test results.
- Verify that executed analytical tests match their corresponding written test methods to ensure procedural compliance and data integrity.
- Evaluate chromatographic data quality by examining peak resolution, baseline stability, and system suitability parameters to ensure analytical methods meet established performance criteria.
- Examine analytical data packages systematically to verify completeness of testing protocols, accuracy of results, and adherence to GMP standards
Ensure compliance with Good Manufacturing Practice regulations throughout all data review activities, maintaining consistent adherence to quality standards.
On average this should be about 5% of your time. Among other things this means we expect you to:
- Apply current FDA guidance documents and company policies and procedures to data review processes.
- Demonstrate proficiency in quality system procedures and work instructions.
- Complete continuing education on evolving GMP regulations.
Identify and document data discrepancies, anomalies, and deviations in analytical results, ensuring comprehensive investigation and resolution of all quality issues.
On average this should be about 5% of your time. Among other things this means we expect you to:
- Review deviation reports to assess completeness and evaluate quality standards compliance
- Coordinate with laboratory personnel to clarify questionable data points.
Execute data integrity assessments across analytical datasets, identifying potential compliance risks and ensuring adherence to data governance standards.
On average this should be about 5% of your time. Among other things this means we expect you to:
- Audit electronic records for completeness and authenticity markers.
- Review audit trails for unauthorized modifications or deletions.
QUALIFICATION, EDUCATION & EXPERIENCE
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.
Required:
- A bachelor's degree in Chemistry or equivalent work experience
- A basic familiarity with Waters Empower
- At least one previous role involving work in an analytical laboratory
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the principal roles and responsibilities of this job.
- Exposure to heated/air conditioned, ventilated facilities with florescent lighting;
- Exposure to building where a variety of chemical substances are used for cleaning, and/or operation of equipment;
- The noise level in the work environment is usually minor;
- Duties are performed indoors;
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
PHYSICAL, SENSORY, COGNITIVE & NEUROLOGICAL DEMANDS
While performing the duties of this job:
- The employee may be required to stoop, bend, squat, kneel, reach, stand, walk, lift, pull, push, grasp, talk, hear, see and use repetitive motions;
- Specific vision abilities required include close vision such as to read handwritten or typed material and the ability to adjust focus;
- The position requires the individual to meet multiple demands from several people and interact with internal and external people;
- Employee moves about the building and be able to maneuver in tight spaces between desks, etc.;
- Employee may have duties involving walking on even or uneven surfaces;
- Employee occasionally to frequently use a whiteboard, which can require grasping whiteboard pens, reaching at, below, or above shoulder height and may require trunk or neck rotation to look back;
- Employee may use computers, overhead projectors, TV, and other work-related equipment, which may require an approximately 25 pound force to push or pull equipment;
- It is necessary to grasp and manipulate pens, markers, scissors, staplers, etc. occasionally to frequently.
- Employee must see and hear on a continuous basis as well as speak frequently;
- Position varies from standing, sitting, walking, etc. On some occasions it may be necessary to move quickly, run, etc. over smooth or uneven surfaces.
ProMed offers a generous benefits package including:
- 401k with company match
- Profit Sharing program
- Medical Insurance
- Health Savings Account/Flexible Spending Account
- Dental Insurance
- Vision Insurance
- Life Insurance
- Short, and Long-Term Disability Insurance
- Critical Illness, Accident, and Identity Theft Protection
- Pet Insurance
ProMed does not discriminate in employment opportunities or practices on the basis of race, color, creed, religion, national origin, ancestry, age, sex, marital status, order of protection, disability, military status, sexual orientation, gender identity, pregnancy, public assistance, family status, unfavorable discharge from military service, genetic information or other segmenting factor protected by law, or local human rights commission activity.
Salary : $50,000 - $65,000