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Cmc Reviewer Jobs in Ohio (NOW HIRING)

CMC Group Inc

Finishing - Operator I

Bowling Green, OH · On-site

$16 - $19.25/hr

CMC Group , located in Bowling Green, Ohio , is seeking a motivated individual to join our ... Review orders (job packets) and art proof to verify the art specifications match the printed labels ...

CMC Group, Inc

Finishing - Operator I

Bowling Green, OH

$16 - $19.25/hr

CMC Group is clean, and a temperature-controlled facility. CMC Group offers a comprehensive ... Review orders (job packets) and art proof to verify the art specifications match the printed labels ...

CMC Group Inc

Finishing - Operator I

Bowling Green, OH · On-site

$16/hr

CMC Group , located in Bowling Green, Ohio , is seeking a motivated individual to join our ... Essential Duties: • Review orders (job packets) and art proof to verify the art specifications ...

Option Care

Nutrition Care Coordinator

Columbus, OH · On-site

$17.02 - $28.38/hr

... review of supply inventory by completing the ENT-Enteral Refill Assessment and processing of Delivery Tickets either via PHD drop shipments or for CMC shipment as needed, coordinating any necessary ...

Option Care Health

Nutrition Care Coordinator

Columbus, OH · On-site

$17.02 - $28.38/hr

... review of supply inventory by completing the ENT-Enteral Refill Assessment and processing of Delivery Tickets either via PHD drop shipments or for CMC shipment as needed, coordinating any necessary ...

University Hospitals

Paramedic I

Beachwood, OH

Three Peer Reviews required for Level II and III * Criteria to Promote and Maintain (five for Level ... PALS (exception CMC) (Required within 6 Months) * Paramedic Specialty Certification (doesn't ...

University Hospitals

Paramedic I

Beachwood, OH

Three Peer Reviews required for Level II and III * Criteria to Promote and Maintain (five for Level ... PALS (exception CMC) (Required within 6 Months) * Paramedic Specialty Certification (doesn't ...

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Cmc Reviewer information

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 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 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 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 are popular job titles related to Cmc Reviewer jobs in Ohio?

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

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

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

What cities in Ohio are hiring for Cmc Reviewer jobs?

Cities in Ohio with the most Cmc Reviewer job openings:

Cmc Reviewer jobs near you

Finishing - Operator I

Bowling Green, OH • On-site

CMC Group Inc
See more jobs at CMC Group Incexternal

$16 - $19.25/hr

Full-time

Medical, Dental, Vision, Life, Retirement

Re-posted 10 days ago

Job description

Description:

 CMC Group, located in Bowling Green, Ohio, is seeking a motivated individual to join our Production Team. This role is a great opportunity to become part of a stable, growing manufacturing organization that values teamwork, safety, and long-term careers. CMC Group is clean, and a temperature-controlled facility.

CMC Group offers a comprehensive benefits package to support our employees, including Medical, Dental, Vision, Disability, and Life Insurance, along with other valuable offerings. Employees are also eligible to participate in our 401(k) retirement plan, with CMC Group matching 100% of employee contributions up to 6% of annual pay, helping you invest confidently in your future.

Summary of Position:

To operate multiple pieces of finishing equipment and processes with speed and accuracy. 

Essential Duties:

• Review orders (job packets) and art proof to verify the art specifications match the printed labels, including small details and color accuracy.

• Verify the product is completed to the customer specifications. 

• Run rewinding and finishing equipment with quality standards, minimal scrap and acceptable productivity levels.

• Slit and rewind stock with precision.

• Keep work area and supply areas organized and clean.

• Inform immediate Supervisor of key issues daily.

• Observe company policies and be a productive team member.

• To remain vigilant for/safeguard against sanitation, pest control and contamination concerns.

• It is the responsibility of all team members to ensure product integrity. Products should be monitored for signs of contamination or quality defects and issues segregated and reported.   

• It is the responsibility of all team members to ensure process integrity. Potential sources of contamination or impacts on performance or quality should be reported promptly.

• Any other duties assigned by supervisor.



Requirements:

Knowledge, Skills and Abilities:

  • Mechanical aptitude.
  • Ability to read ruler to increments of 1/64”
  • Ability to accurately log each job in current ERP or capture manual logging details as necessary to record correct labor on job(s)
  • Ability to work with independently 
  • Ability to do simple math     
  • Attention to detail     
  • Ability to interact with other departments
  • Must be available for overtime
  • Ability to work well with peers and supervisors. 
  • Flexibility to switch to different areas and tasks as needed

Training and Experience:

  • High school diploma or GED equivalent.

Physical Requirements:

  • Climbing – ascending and descending
  • Stooping, reaching, standing, 
  • Pushing, pulling and using pushcart, 
  • Lifting up to 50-75 pounds occasionally, and/or up to 20 pounds frequently, and/or up to 10 pounds constantly to move objects
  • Fingering, grasping and feeling.
  • Talking, hearing and repetitive motion
  • Medium work-exerting up to 50 pounds of force occasionally, and/or up to 20 pounds of force frequently, and/or in excess of 10 pounds of force constantly to move objects.
  • Required to have visual acuity to determine the accuracy, neatness, and thoroughness of the work assigned or to make general observations of facilities or structures.
  • Subject to hazards including a variety of physical conditions, such as proximity to moving mechanical parts, moving vehicles, electrical current, and climbing.
  • Required to function in narrow aisles.


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