QC Microbiology Analyst I

Employer
Planet Pharma
Location
South San Francisco, California, US
Salary
Competitive
Posted
May 01, 2021
Closes
May 07, 2021
Ref
2153766707
Discipline
Biology
Employment Type
Full time
Salary Type
Salary
The Role

The Analyst I, Quality Control Microbiology will support Quality Control testing of drug substances and process intermediates in support of clinical development and commercial programs. This position will be located in South San Francisco.

Primary Responsibilities:

• Support Quality Control testing of drug substances and process intermediates in support of clinical development and commercial programs

• Perform microbiological analyses under cGMP and GLP guidelines

• Perform bioburden, endotoxin, pH/Conductivity and other tests as needed

• Perform viable air, non-viable particulate, surface/swab environmental monitoring (EM) of manufacturing areas

• Perform gas and utilities testing,

• Perform sampling and testing for purified water

• Perform growth promotion/media qualification and gram staining

• Perform plate reading, generate microbial isolates, and shipping of isolates for identification

• Receive, unpack and organize supplies for QC areas

Revise SOPs and Forms

• Perform/support deviation and OOS investigations, as needed

• Support method validation, assay development, routine, and non-routine study protocols

• Support Fill and Finish operations

• Assist in data trending and summarization

• Perform routine cleaning, schedule equipment preventative maintenance, and organization of laboratory areas in accordance to cGMP

Must Have/Required:

• Bachelor's Degree in chemistry, biology or microbiology with 0-2+ years' relevant microbiology laboratory experience in Pharmaceutical/Biotech.

• Excellent knowledge of Aseptic technique and common microbiological testing

• Interpersonal skills and ability to contribute to the success of a team

• Must be able to gown into cleanrooms in support of testing and manufacturing activities

• Good documentation and data organization

• Detail oriented and willingness to learn

• Proven history of working in a fast-paced team environment, time management, and meet deadlines

• Team player with the ability and willingness to support other colleagues in the Quality Control department. This support may include future cross training with analytical assays as needed.

• Must be willing to work second shift, rotating shifts, overtime, weekends, and holidays, as required

• Models our Core Values: Be Bold, Care Deeply, #GetStuffDone - is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted.

Physical Demands and Work Environment:

Must be proficient in use of computer, particularly Microsoft Word and Excel programs, and be able to sit/stand and be gowned inside the cleanroom for extended periods of time. Some lifting required (not more than 50 lbs). Use of a respirator may be required. Exposure to biohazards and viruses. Routinely able to stand, walk, kneel and crouch while performing sampling, such as environmental monitoring.

This position description intends to describe the general nature and level of work being performed by people assigned to this job. It is not intended to include all duties and responsibilities. Other responsibilities and task may be assigned.

Education:

Bachelor's Degree in chemistry, biology or microbiology with 0-2+ years' relevant microbiology laboratory experience in Pharmaceutical/Biotech.

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