Website Aditi Consulting
Aditi Consulting
Company : Aditi Consulting
Payrate: $25.00 – $28.00/hr.
Summary:
This position includes 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 with QC Support. The analyst will be responsible for ensuring that CSL samples are tested and reviewed according to quality requirements and results reported are valid, accurate, and documented per applicable regulatory and corporate requirements.
Responsibilities:
- QC Microbiology Accountabilities:
- Performs testing and associated tasks without errors per applicable SOPs and protocols.
- Completes 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 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 acquiring 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 Required 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 are a plus.
- Intermediate knowledge of analytical methods and related instrumentation is a plus.
Pay Transparency: The typical base pay for this role across the U.S. is: $25.00 – $28.00/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
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Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying for this position, you agree to Aditi’s use of AI technology, including calls from an AI Voice Recruiter.
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