QC Inspector

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Job Title:
Quality Control Inspector – Grade I
Department:
Quality
Division:
Clinical Services
Location: Durham, NC
 

Summary Objective of position:

Inspect operational activities for compliance to cGMPs, Almac SOPs, and other written quality and customer standards.

Essential Functions:

Percentage
A
Inspect clinical labels prepared by Almac Label Control to ensure that labels are acceptable for use in accordance with GMPs, Almac SOPs, and customer requirements. Approve labels prior to issuance into packaging operations.
20%
B
Inspect incoming goods to ensure that clinical trial materials are acceptable for use in accordance with GMPs, Almac SOPs, and customer requirements. Reviews inspections and provides batch disposition on incoming goods.
20%
C
Inspect labelling and assembly operations to evaluate and monitor the quality of each batch independent from Production to ensure that operations are carried out in compliance with GMPs, Almac SOPs, and customer requirements.
20%
D
Inspect the processing of distribution orders, destined for a clinical site or depot, to ensure compliance with GMP/GDPs, Almac SOPs, distribution instructions, and customer requirements.
20%
E
Interacts with Quality, Operations, and Project Services personnel at any Almac site to report, address, and resolve quality issues.
20%

Additional Functions:

 
1. Sample clinical trial material and components in accordance with Almac SOPs to maintain product integrity, prevent cross-contamination, and ensure full traceability
 
2. Review/ approve expiry updates as well as change lot status of clinical trial materials as requested and in accordance with Almac SOPs. This may require a review of lot status or expiry dates for CTM located at other Almac sites.
 
3. Handle other tasks as delegated by QC Supervisor such as changing/reviewing temperature charts or checking clinical supplies scheduled for destruction.
Behavioral Requirements:
  • Handling multiple responsibilities and job tasks (multi-tasking) as needed.
  • Communicate clearly and consisely.
  • Demonstrating attention to detail.
  • Flexibility with work requirements, work environment and fast-paced/changing job needs.
 
Promoting teamwork by:
  • Collaborating with co-workers.
  • Attending staff meetings as required.
  • Meeting individual company goals as established.
  • Establishing rapport and maintaining positive communication with others, demonstrating respect and support, cooperating and flexibility with change.
  • Adhering to company and department policies.
General Requirements:
Quality:
Adhere to all Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP).
Training & Development:
Ensure training has been received before undertaking specific duties and that all training is documented in training records.
Health & Safety:
  • Understand the company’s Health & Safety Policy and follow all associated procedures.
  • Report all accidents or awareness of any unsafe conditions in the workplace to management.
Human Resource Management:
Conform to the company’s policies contained in the Employee Handbook.

Basic Qualifications & Position Requirements:

Required Education:

  • High School Diploma/GED
 

Preferred Education:

  • Associates or Bachelor's degree with science background
 

Required Work Experience:

  • 6 + months experience in GMP manufacturing, packaging, and/or quality assurance/control or equivalent
 

Preferred Knowledge:

  • GMP training and computer literacy preferred

 

Skills:

  • Effective oral and written communication skills
  • Organizational skills
 

Additional Qualifications:

·Ability to work overtime on weekdays and weekends when necessary

 

Work Environment & Dress attire

Will work in Production and Warehouse areas including limited time in cold storage units. Business casual dress.
 
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