Quality Control Analyst

Job Title: Quality - Quality Control Analyst

Location:   Holly Springs, NC 27540

Duration- 12 Months (Possible extension for longer duration)

Weekly shifts will be Wednesday to Saturday; 10-hours daily with flexible start/end times
 

Please note, a current flu vaccine is required for this role.

Job Description:
Primary responsibilities for this position include performing tasks associated with critical testing on raw materials, environment, utilities, validation samples, and manufactured materials. The analyst will be responsible for ensuring that , samples are tested and reviewed according to quality requirements and results reported are valid, accurate, and documented per applicable regulatory and corporate requirements. Analysts may be required to perform or participate in tasks associated with method validation and transfers.

• Performs testing and associated tasks without errors per applicable SOPs and protocols.
• Complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements as written.
• Develops and maintains SOPs
• Develops expertise in assigned assays/techniques
• Authors lab investigation and invalid assay assessments
• May be required to perform shift work as required to support the operations

Minimum Required Qualifications:
• Bachelor's degree in a Scientific discipline required.
• Recent college graduates (entry level / no experience) is acceptable.

Preferred / Nice to Have Qualifications:
• Degree in Biology or Microbiology is highly preferred.
• Experience with environmental monitoring in a pharmaceutical manufacturing environment is nice to have.
• Experience with working in an analytical testing lab (academic or industry) is nice to have.
• Experience working in a cGMP Pharmaceutical Laboratory is nice to have.
• Experience with Laboratory Information Management Systems (LIMS) is nice to have.
• Experience performing Bioburden, Endotoxin, Sterility is nice to have.
• Intermediate knowledge of GMPs, safety regulations and data integrity is a plus.
• Intermediate knowledge of analytical methods and related instrumentation is a plus