Quality Control Analyst

Target PR Range: 20-30/hr
*Depending on experience

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 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 in a timely manner, running of the autoclave and parts washer, and will assist 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 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

QC Support Accountabilities:
• Responsible for Lab services, which includes 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 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 with going above and beyond to help others

Minimum Required Qualifications:

• Bachelor's 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:

• 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.