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Cmc Reviewer Jobs in Oregon (NOW HIRING)

Option Care

Nursing Quality Assurance Auditor - LPN

Salem, OR · Remote

$57/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

... CMC and area leadership of upcoming scheduled QSA to support awareness, preparation, and planning. * Escalate opportunities for training and education identified during QSA to manager for review and ...

New

Timberlab

Production Detailer

Portland, OR

... for CMC machining and install efforts. POSITION RESPONSIBILITIES AND DUTIES * Interact with ... Track task assignments through initial development, performance, review, and feedback

Timberlab

Production Detailer

Portland, OR · On-site

... for CMC machining and install efforts. POSITION RESPONSIBILITIES AND DUTIES * Interact with ... Track task assignments through initial development, performance, review, and feedback

Timberlab

Production Detailer

Portland, OR · On-site

... for CMC machining and install efforts. Position Responsibilities And Duties * Interact with ... Track task assignments through initial development, performance, review, and feedback

Avalyn Pharma

OR

CMC Regulatory Support * Author and review analytical sections of regulatory submissions, including INDs, IMPDs, CTAs, NDA/BLA Module 3 documentation, annual reports, regulatory responses, and ...

New

All JobsCmc Reviewer JobsCmc Reviewer Jobs in Oregon

Cmc Reviewer information

What is the difference between Cmc Reviewer vs Cmc Associate?

AspectCmc ReviewerCmc Associate
Required CredentialsBachelor's degree, often in life sciences or chemistry; relevant experienceSimilar educational background; entry-level or junior role
Work EnvironmentRegulatory or pharmaceutical companies, quality assurance teamsSame industry, often in early career stages
Employer & Industry UsageUsed in biotech, pharma, and regulatory sectors for review rolesCommonly a starting position in CMC departments
Comparison Search IntentUnderstanding seniority and responsibilitiesEntry-level role, learning responsibilities

The main difference between a Cmc Reviewer and a Cmc Associate lies in experience and responsibility. Cmc Reviewers typically have more experience and are responsible for critically evaluating CMC documentation, while Cmc Associates are often entry-level, supporting review processes. Both roles require similar educational backgrounds and are integral to pharmaceutical and biotech industries.

What is a CMC reviewer?

CMC Reviewers are professionals who evaluate the Chemistry, Manufacturing, and Controls (CMC) sections of regulatory submissions for pharmaceuticals and biologics. Their main responsibility is to ensure that products are manufactured consistently and meet quality standards required by regulatory agencies such as the FDA. They assess data on product composition, manufacturing processes, quality control, and stability to ensure compliance with regulations. CMC Reviewers play a critical role in the drug approval process by helping to ensure the safety, efficacy, and quality of new therapies.

What are some common challenges faced by CMC reviewers in coordinating with cross-functional teams during the regulatory submission process?

CMC Reviewers often encounter challenges in aligning documentation and data from various departments such as manufacturing, quality control, and research. Differences in terminology, documentation standards, and timelines can cause delays or inconsistencies in submissions. Effective communication, proactive project management, and a strong understanding of regulatory requirements are crucial for ensuring all contributions meet submission standards and deadlines. Building strong relationships with stakeholders and establishing clear documentation processes can help mitigate these challenges.

What are the key skills and qualifications needed to thrive as a CMC reviewer?

To thrive as a CMC Reviewer, you need in-depth knowledge of chemistry, manufacturing, and controls (CMC) regulations, as well as a degree in pharmacy, chemistry, or a related scientific field. Familiarity with regulatory submission systems like eCTD, and experience with ICH guidelines and FDA/EMA standards, are typically required. Strong attention to detail, critical thinking, and effective communication skills help reviewers assess complex data and collaborate with cross-functional teams. These capabilities ensure regulatory compliance and product quality, facilitating timely drug approvals and patient safety.

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

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

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

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

Cmc Reviewer jobs near you
Infographic showing various Cmc Reviewer job openings in Oregon as of August 2026, with employment types broken down into 76% Full Time, 17% Part Time, and 7% Contract. Highlights an 51% Physical, 2% Hybrid, and 47% Remote job distribution.

Nursing Quality Assurance Auditor - LPN

Option Care Enterprises, Inc.

Salem, OR • Remote

$5/hr

Full-time

Posted 3 days ago

New

Job description

Extraordinary Careers. Endless Possibilities.

With the nation’s largest home infusion provider, there is no limit to the growth of your career.

 Option Care Health, Inc. is the largest independent home and alternate site infusion services provider in the United States. With over 8,000 team members including 5,000 clinicians, we work compassionately to elevate standards of care for patients with acute and chronic conditions in all 50 states. Through our clinical leadership, expertise and national scale, Option Care Health is re-imagining the infusion care experience for patients, customers and team members.

Join a company that is taking action to develop an inclusive, respectful, engaging and rewarding culture for all team members. At Option Care Health your voice is heard, your work is valued, and you’re empowered to grow. Cultivating a team with a variety of talents, backgrounds and perspectives makes us stronger, innovative, and more impactful. Our organization requires extraordinary people to provide extraordinary care, so we are investing in a culture that attracts, hires and retains the best and brightest talent in healthcare.

Job Description Summary:

Reporting to the Director, Clinical Services Nursing, the Nursing Quality Assurance Auditor supports OCH’s Clinical and Quality standards through on location and remote reviews to monitor performance. The Nursing Quality Assurance Auditor is responsible for the on-going facilitation and completion of the Quality Assessment (QA) process for assigned locations. The Nursing Quality Assurance Auditor will have thorough understanding of the underlying policies, procedures and standards measured in QAs and supports team member understanding and comprehension of them. Establishes positive working relationships with leaders and staff at audited locations and serves as a visible member of the Clinical Services Organization, modeling our Values and commitment to quality at all times.

Job Description:

Job Responsibilities (listed in order of importance and/or time spent)

  • Management and completion of on-site AIS Quality Assessment Standards for assigned facilities during each assessment period throughout the calendar year.
  • Partners with Remote Nursing Quality Assurance Auditor to add AIS standard scores to overall CMC QSA standards and score.
  • Partners with Remote auditor on findings to ensure opportunities for improvement are included in the plan of Correction for the CMC.
  • Partners with Remote nursing auditor on development of schedule for upcoming assessment period.
  • Provides advanced notice to CMC and area leadership of upcoming scheduled QSA to support awareness, preparation, and planning.
  • Escalate opportunities for training and education identified during QSA to manager for review and follow through.
  • Escalate quality questions and support needed to manager or others as appropriate in a timely fashion to ensure appropriate response and directions is provided.
  • Ensure the AIS set up follows federal, state, and local rules and regulations as well as accreditation standards and OCH policy and procedure.
  • Other duties as assigned
Supervisory Responsibilities

Does this position have supervisory responsibilities?

(i.e. hiring, recommending/approving promotions and pay increases, scheduling, performance reviews, discipline, etc.)

No - X       

Yes        

Basic Education and/or Experience Requirements

  • Required licensure as a Licensed Practical Nurse as granted by the appropriate state licensing authority.
  • At least 1-2 years of patient facing experience

  • High School diploma or GED required.

Basic Qualifications

  • Basic knowledge of Federal, State, and local rules and regulations as well as familiarity with Accreditation standards, preferable ACHC.
  • Experience in evaluating processes for compliance federal, state, and local regulations.  Accreditation standards and requirements as well as company policy.
  • Proficient communication skills, verbal, written and ability to develop and conduct presentations.
  • Experience with planning, organizing, and managing tools and resources for successful completion of projects, goals, and objectives.
  • Working knowledge of Microsoft Office-Excel, Word, Outlook, PowerPoint, Teams, and use of One Drive.
  • Physical Demand Requirements
  • Ability to work on a personal or laptop computer for extended periods of time.
  • Ability to travel up to 80% of the time.

Travel Requirements:  (if required)

  • Willing to travel up to 80% of the time for business purposes within state and out of state.

Preferred Qualifications & Interests (PQIs)

  • Knowledge of Infusion Nursing Standards
  • Knowledge of accreditation standards such as ACHC and JACHO.
  • Knowledge of CMC standards as it relates to Home Infusion

Due to state pay transparency laws, the full range for the position is below:

Salary to be determined by the applicant's education, experience, knowledge, skills, and abilities, as well as internal equity and alignment with market data.

Pay Range is $57,187.58-$95,312.63

Benefits:

-Medical, Dental, & Vision Insurance

-Paid Time off

-Bonding Time Off

-401K Retirement Savings Plan with Company Match

-HSA Company Match

-Flexible Spending Accounts

-Tuition Reimbursement

-myFlexPay

-Family Support

-Mental Health Services

-Company Paid Life Insurance

-Award/Recognition Programs

Option Care Health subscribes to a policy of equal employment opportunity, making employment available without regard to race, color, religion, national origin, citizenship status according to the Immigration Reform and Control Act of 1986, sex, sexual orientation, gender identity, age, disability, veteran status, or genetic information.