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Gmp Data Reviewer Jobs in Oregon (NOW HIRING)

Fortis Construction

GMP Accountant

Portland, OR · On-site

The responsibility for reviewing and verifying compliance activities for GMP Trade Partners on a ... Keen analytical, organizational and problem-solving skills which allow for strategic data ...

Stark Pharma Solutions Inc

Senior Process Engineer

Bend, OR · On-site

$109K - $141K/yr

... reviews, vendor management, and facility implementation within a GMP-regulated environment. The ... Data Sheets * Equipment Calculations * Technical Drawings * Provide oversight and technical ...

Lonza

Operations Production Specialist

Bend, OR · On-site

$54K - $72K/yr

Review completed batch records and electronic data to ensure accuracy, completeness, and data integrity. * Support GMP compliance activities, investigations, corrective actions, and process changes.

Shimento, Inc.

CQV Validation Specialist

Bend, OR · On-site

... and GMP equipment while partnering closely with both the Instrumentation and CQV teams. The ... Develop, execute, review, and maintain validation lifecycle documentation, including: * Risk ...

Lonza

Operations Production Specialist

Bend, OR · On-site

$54K - $72K/yr

Review completed batch records and electronic data to ensure accuracy, completeness, and data integrity. * Support GMP compliance activities, investigations, corrective actions, and process changes.

Genentech

Principal Project Scheduler

Hillsboro, OR · On-site

$119K - $222K/yr

You will support RFP preparation, bid reviews, and vendor/contractor evaluations to assess schedule ... Biotech & GMP Specialist: You bring hands-on experience with biotech or pharmaceutical CAPEX ...

Tailored Management

Validation Engineer 2

Bend, OR · On-site

$70.92 - $99.29/hr

... and GMP equipment while partnering closely with the Instrumentation and CQV teams . The ideal ... Develop, execute, review, and maintain validation lifecycle documentation, including: * Risk ...

S+B James Construction

Estimator

Medford, OR · On-site

$90K - $130K/yr

Conducts reviews of milestone documents for the development and pricing of value alternative ... Participates in hard bid/estimating and GMP budgeting activities by soliciting subcontractor ...

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Gmp Data Reviewer information

What is a GMP data reviewer?

GMP Data Reviewers are professionals responsible for reviewing and verifying data generated in Good Manufacturing Practice (GMP) environments, typically within the pharmaceutical, biotechnology, or medical device industries. Their main role is to ensure that all laboratory and manufacturing records comply with regulatory and quality standards, such as those set by the FDA or EMA. They meticulously check documentation for accuracy, completeness, and adherence to protocols to support product quality and regulatory compliance. GMP Data Reviewers often collaborate with laboratory analysts, quality assurance teams, and regulatory affairs to resolve discrepancies and maintain data integrity.

What are the key skills and qualifications needed to thrive as a GMP data reviewer, and why are they important?

To thrive as a GMP Data Reviewer, you need a solid understanding of Good Manufacturing Practices, analytical techniques, and a relevant science degree or equivalent experience. Familiarity with laboratory information management systems (LIMS), chromatography data systems, and knowledge of regulatory documentation standards is essential. Attention to detail, critical thinking, and effective communication are vital soft skills for identifying discrepancies and ensuring compliance. These competencies are crucial to maintain data integrity and regulatory compliance in pharmaceutical manufacturing processes.

What are some common challenges faced by GMP data reviewers during the documentation review process?

GMP Data Reviewers often encounter challenges such as inconsistent data entries, incomplete documentation, and discrepancies that require clarification with laboratory or production staff. Managing tight deadlines while ensuring compliance with regulatory standards can also be demanding. Effective communication with cross-functional teams is essential for resolving issues quickly and maintaining data integrity, making attention to detail and strong organizational skills crucial for success in this role.

What are popular job titles related to Gmp Data Reviewer jobs in Oregon?

For Gmp Data Reviewer jobs in Oregon, the most frequently searched job titles are:

What job categories do people searching Gmp Data Reviewer jobs in Oregon look for?

The top searched job categories for Gmp Data Reviewer jobs in Oregon are:

Gmp Data Reviewer jobs near you

GMP Accountant

Portland, OR • On-site

Fortis Construction
Construction • 201 - 500 employees
Learn more about Fortis Constructionexternal

Full-time

This job post has expired today. Applications are no longer accepted.

Job description

Job Description:

The Guaranteed Maximum Price (GMP) Accountant is an integral member of the project team and plays a key role in reviewing and tracking GMP Trade Partner billings, collaborating with team members, external auditors, and owners to enhance the auditing process and streamline workflows. This role performs many vital accounting responsibilities and is responsible for the auditing processes that are required to maintain and ensure compliance with owner standards, federal regulations, and state regulations.
A successful GMP Accountant is detail oriented with good problem-solving skills and the ability to interact and communicate positively and successfully with all levels of the organization. The responsibility for reviewing and verifying compliance activities for GMP Trade Partners on a construction project requires a proactive approach, thorough knowledge of accounting systems, and a strong working knowledge of contract guidelines and change orders that have been processed. The GMP Accountant must be a role model of Fortis core values.
  • Conducts GMP Trade Partner billing audits monthly, quarterly, and final GMP Trade Partner audit to finalize the Trade Partner Agreement.
  • Assists the preconstruction and contract administration departments with development of GMP Trade Partner Agreements to ensure compliance with owner auditing guidelines.
  • Confirms Trade Partner compliance on a month-to-month basis by reviewing contract documents, billing records, and accepted billing practices.
  • Verifies expenses being invoiced via GMP Trade Partner billings meet criteria and guidelines set forth by owner.
  • Communicates and resolves audit findings with project team, GMP Trade Partner, and owners.
  • Creates and analyzes project-specific reports for job cost information as needed by the project team.
  • Cultivates relationships with architects, owners, external auditors, owner representatives, and trade partners.
  • Collaborates, mentors, and trains other team members in GMP accounting requirements and responsibilities.
  • Reconciles financial discrepancies by collecting and analyzing account information.
  • Answers accounting procedure questions by researching and interpreting accounting policy and regulations.
  • Maintains customer confidence and protects operations by keeping financial information confidential.
  • Assist in other duties as assigned, relevant to the achievement of the position's and team's objectives.

REQUIRED QUALIFICATIONS

  • Minimum of 3 years of relevant experience in construction industry.

  • Bachelor's degree in accounting or related degree program, or equivalent work experience.

  • Advanced Microsoft Excel skills are essential.

  • Keen analytical, organizational and problem-solving skills which allow for strategic data interpretation versus simple reporting.

  • Strong interpersonal and communication skills.

  • Ability to think strategically and make connections between diverse issues and tasks.

  • Demonstrates a proactive, hands-on work style with meticulous attention to detail, curiosity, and strong resilience.

  • Willingness to work a flexible schedule during peak periods and able to meet timelines consistently.

  • Ability to work independently and with various teams internally and externally.

  • Understanding of various types of construction contracts and subcontracts.

  • Must possess a valid driver's license and a satisfactory driving record in accordance with Fortis policy.

PREFERRED QUALIFICATIONS

  • Working knowledge of an ERP system.

  • Ability to quickly learn new software systems and procedures.

PHYSICAL REQUIREMENTS

  • Work is performed in a professional office environment. Role is stationary, often standing or sitting for long periods of time. Utilize standard office equipment such as computers, phones, photocopiers, etc. Communication with internal and external contacts, including speaking and hearing. May occasionally push, pull or lift up to 25 lbs.

TRAVEL REQUIREMENTS

  • Occasional travel.

  • All Fortis positions require some level of driving.

RQ-0745 GMP Accountant (Open)

The above description is intended to identify the essential functions and requirements for the performance of this job; it is not to be construed as a complete statement of duties, responsibilities or requirements. All jobs require behaviors consistent with our Core Values and Culture. The employee must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations could be made to enable employees with disabilities to perform the essential functions of the role, absent undue hardship. Fortis Construction, Inc. reserves the right to revise the job description at any time.


Fortis is an Equal Employment Opportunity employer. We adhere to a policy of making employment decisions without regards to race, color, religion, sex, age, disability or any other protected categories. It is our intention that all qualified applicants be given an equal opportunity and that selection decisions be based on job-related factors.

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