Website CCL Clicnial Systems

Bringing a new drug to market successfully is a complex and exacting process with huge investments of time and money. But effective therapies can save lives and improve the quality of life for millions of patients.

CCL Clinical Systems – Garden City, NY

Full Job Description

Position: Assistant Manager of Quality Assurance

Company: CCL Clinical Systems provides clinical labels and data management services to the pharmaceutical industry to help them successfully conduct clinical trials.

Summary: This position entails management of Quality Assurance staff and daily Quality Assurance functions supporting Clinical Systems, Inc. contract label generation operations. This position reports to the Manager of Quality Assurance.

Assistant Manager of Quality Assurance Requirements:

  • 3 Years of QA Management Experience.
  • College degree, preferably in a technical area.
  • Excellent analytical skills.
  • Excellent organizational skills.
  • Excellent communications skills.
  • Advanced computer skills.
  • Good mathematical skills and grammatical knowledge.
  • Ability to follow detailed verbal and written instructions.
  • Ability to proof read printed material and check written documentation.
  • Full knowledge of cGMP regulations and operational SOPs.
  • Understanding of CAPA requirements in a cGMP environment.
  • Familiarity with Clinical Labeling a plus.
  • Familiarity with Global Vision proofing systems a plus.

Assistant Manager of Quality Assurance Responsibilities:

  • Independently manage the QA staff.
  • Prepare and implement operational SOPs.
  • Maintain and update documents related to operations.
  • Overall control of operational procedures.
  • Preparation and conducting cGMP and SOP training sessions.
  • Enforce proper cGMP practices and full adherence to SOP requirements related to operations.
  • Review documents and determine disposition of all products.
  • Conduct/handle internal, vendor, and customer audits.

Assistant Manager of Quality Assurance Training:

  • cGMP training
  • SOP training
  • On the job training
  • Prior experience

Working Conditions: CCL Clinical Systems provides a clean and safe work environment for all employees.

Confidentiality Statement: Based on the nature of our business, it is understood that all customer related clinical trial data is confidential. Upon hire, each employee is required to adhere to that confidentiality.

Job Type: Full-time

Benefits:

  • 401(k)
  • Dental insurance
  • Health insurance
  • Life insurance
  • Paid time off
  • Vision insurance

Schedule:

  • 8 hour shift
  • Day shift
  • Monday to Friday

Education:

  • Bachelor’s (Preferred)

Experience:

  • QA Management: 3 years (Preferred)

Work Location:

  • One location

Work Remotely:

  • No

Location

CCL Clinical Systems in Garden City, NY 11530

About CCL Clinical Systems

At CCL Clinical Systems we focus on producing clinical label products that meet the strict requirements of the pharmaceutical and biopharmaceutical industries and have led the way in innovations, accuracy and quality. We’ve developed the most powerful software tools in the industry which drive our entire design and manufacturing process so every label is 100% accurate every time.

Our customer service representatives are always responsive to your needs. Since 1987 we’ve developed a subject-matter expertise that can help guide clients, advise them on potential problems or help find solutions to challenges unique to their trial.

Why Join the CCL Team

  • Competitive Wages
  • Profit Sharing
  • 6% 401K Matching
  • Career Advancements
  • Healthcare Benefits
  • Recession Proof Industry
  • Positive Impact on Community
  • Abundant Training and Professional Development
  • Passionate Team
  • Outstanding Industry Reputation
  • Work Independently or as a Team

CCL provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

To apply for this job email your details to maureen.kinney@clinsys.net