Quality Control Analyst

The Fountain Group is currently seeking a Quality Control Analyst for a prominent client of ours. This position is located in Holly Springs, NC. Details for the position are as follows:

Job Title: Quality Control Analyst

Pay: $25-30

Duration:1 year

Location: 100% onsite at client site in Holly Springs, NC

Shift/Schedule Details: Wednesday - Saturday, 10 hour days, must be present for first meeting of the day at 8:15am, otherwise can be flexible

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 QC Microbiology samples are collected, tested, and reviewed according to quality requirements and results reported are valid, accurate, and documented per applicable regulatory and corporate requirements.
• Analyst 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 Requirements (Must Have):

1 - BS/BA in Biology or Microbiology or other related science field

2 - Experience with environmental monitoring in manufacturing areas

3 - Some experience with working in an analytical testing lab (academic or industry)

Desired Requirements (Nice to Have):

1 - Experience working in a cGMP Pharmaceutical Laboratory

2 - Experience with Laboratory Information Management Systems (LIMS)

3 - Experience performing Bioburden, Endotoxin, and Sterility

What to look for:

• Bach degree in a scientific discipline - microbio/bio preferred
• Prior EM experience within a manufacturing environment
• EM experience
• Other analytical microbiology also good to update

What to update:

• cGMP knowledge/experience nice to have
• LIMS nice to have
• Microbio background needed
• Endotoxin / bioburden / sterility a plus
• Good documentation skills
• MS office
• SOP development nice to have
• Lab investigations nice to have
• Authoring lab investigations

If you are interested in hearing more about the position, please respond to this posting with your resume attached.

Please forward this posting to any friends or colleagues as we do offer a Referral Bonus for any candidate hired.

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