Quality Control Analyst

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Job Title: Quality Control Analyst

Location: Holly Springs NC

Job Description:

Primary responsibilities for this position include performing tasks associated with critical testing on raw materials environment utilities validation samples and manufactured materials. This position also has the potential to require performance of tasks associated to QC Support. The analyst will be responsible for ensuring that CSL Seqirus samples are tested and reviewed according to quality requirements and results reported are valid accurate and documented per applicable regulatory and corporate requirements. If work in the QC Support function is required the analyst will also be responsible for ensuring that QC samples are delivered and transported on time running of the autoclave and parts washer and assisting with coordinating QC sample shipments as necessary. The analyst will be required to maintain GMP documentation for all activities and must follow applicable SOPs.

QC Microbiology Accountabilities:

Performs testing and associated tasks without errors per applicable SOPs and protocols.
Complies with policies and procedures 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

QC Support Accountabilities:

Responsible for Lab services which include running a Parts Washer for glassware wrapping materials and appropriately using an Autoclave and delivering samples through the Bulk process by reviewing sample plans before delivery
Responsible for the aliquoting of production material in a BSC
Responsible for processing incoming and outgoing shipments
Able to perform GMP documentation activities and follow specific schedules with excellent communication skills
Works within clearly defined standard operating procedures and/or scientific methods and adheres to quality guidelines
Must demonstrate exceptional teamwork behaviors by going above and beyond to help others

Minimum Required Qualifications:

Bachelors degree in a Scientific discipline required.
Recent college graduates (entry level / no experience) are acceptable.
Must be willing to have a current flu shot.

Preferred / Nice to Have Qualifications:

A degree in Biology or Microbiology is highly preferred.
Experience with environmental monitoring in a pharmaceutical manufacturing environment is nice to have.
Experience 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 and 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.

What will the candidates interview experience look like

The hiring team plans to schedule 3 back-to-back 30-minute onsite interviews so candidates can meet with various stakeholders. The team will try to schedule these on the same day for a total of 90 minutes.

Is there any possibility for future conversion to a full-time employee

Yes this is a possibility but not guaranteed.

Does this role require PPE (not otherwise provided by CSL):

Yes supplier-paid safety shoes are required.

Job Title: Quality Control Analyst Location: Holly Springs NC Job Description: Primary responsibilities for this position include performing tasks associated with critical testing on raw materials environment utilities validation samples and manufactured materials. This position also has th...