Quality - Quality Control Analyst

Mindlance

Holly Springs, NC

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JOB DETAILS

SKILLS

Analysis Skills, Assays, Biology, Environmental Monitoring, Laboratory, Laboratory Information Management System (LIMS), Maintain Compliance, Manufacturing, Materials Testing, Microbiology, Operational Support, Quality Control, Regulations, Regulatory Compliance, Regulatory Requirements, Safety/Work Safety, Standard Operating Procedures (SOP), Testing

LOCATION

Holly Springs, NC

POSTED

1 day ago

Job Description:
Shift/Schedule Details: Wednesday Saturday, 10 hour days, must be present for first meeting of the day at 8:15am, otherwise can be flexible
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 client 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):
BS/BA in Biology or Microbiology or other related science field
Experience with environmental monitoring in manufacturing areas
Some experience with working in an analytical testing lab (academic or industry)

Desired Requirements (Nice to Have):
Experience working in a cGMP Pharmaceutical Laboratory
Experience with Laboratory Information Management Systems (LIMS)
Experience performing Bioburden, Endotoxin, and Sterility
A current flu vaccine is required for this role.

EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.

About the Company

Mindlance

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