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Quality Control Analyst

1 month ago

Holly Springs, United States Planet Pharma Full time

Holly Springs, NC - 100% ONSITE

1 year contract

Target PR: $24-28

Shift/Schedule Details: Monday - Friday (standard business hours)


IMPORTANT PLEASE NOTE - This role requires a current flu vaccine


613591


Job Description:


Primary responsibilities for this position include performing tasks associated with method validations and transfers.

The analyst will be responsible for ensuring that Seqirus validation samples are 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 deviation and invalid assay assessments

• May be required to perform shift work as required to support the operations


Minimum Required Qualifications for Level II:


• 3+ years of laboratory experience OR equivalent

• Intermediate knowledge of GMPs, safety regulations and data integrity

• Intermediate knowledge of analytical methods and related instrumentation

• Experience performing PCR


Minimum Required Qualifications for Level I:

• 6 months or more laboratory experience OR equivalent

• Basic knowledge of GMPs, safety regulations and data integrity

• Basic knowledge of analytical methods and related instrumentation

• Some knowledge of performing PCR


Required for BOTH Level I and Level II:

• BS/BA in Biochemistry, Virology, or other related science field

• Experience with maintaining cell lines, cell passaging, or cell counting techniques

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

• Current flu vaccine


Preferred / Nice to Have Qualifications for either Level:

• Experience working in a cGMP Pharmaceutical Laboratory

• Experience with Laboratory Information Management Systems (LIMS)

• Experience performing Virus Titer assays, Residual Infectious Virus assays and other virology-based testing methods


Does this role require PPE (not otherwise provided by client): yes, safety shoes are required


Reason for request: Holiday/leave of absence coverage