In-Process Analyst, Quality Control (Flex Team)
Company: Peregrine Pharmaceuticals, Inc.
Posted on: June 8, 2021
Avid Bioservices is a dedicated contract development and
manufacturing organization (CDMO) focused on development and cGMP
manufacturing of biopharmaceutical products derived from mammalian
cell culture. We provide a comprehensive range of process
development, high quality cGMP clinical and commercial
manufacturing services for the biotechnology and biopharmaceutical
industries. With 25 years of experience producing monoclonal
antibodies and recombinant proteins in batch, fed-batch and
perfusion modes, our services include cGMP clinical and commercial
product manufacturing, purification, bulk packaging, stability
testing and regulatory strategy, submission and support. We also
provide a variety of process development activities, including cell
line development and optimization, cell culture and feed
optimization, analytical methods development and product
We are dedicated to the improvement of global patient outcomes
by delivering world-class services. Our expertise enables us to
partner with our customers to advance their products from clinical
development to commercial launch. Do you possess the skills and
expertise below to improve patient lives and support patient
innovative therapies? If so, apply today!
The Quality Control Analyst will perform testing and sampling to
support manufacturing, validation, process development and
stability studies in a GMP environment for the QC In-Process
Essential Functions: (Reasonable accommodations may be made to
enable individuals with disabilities to perform the essential
- Perform basic compendial test methods without supervision and
with strict adherence to written protocols, analyze data and report
- Formulate buffers and reagents for the purpose of performing
- Write and revise test methods and procedures
- Perform aseptic sampling.
- Perform the following testing: visual inspection, pH,
conductivity, osmolality, spectrophotometry, endotoxin by LAL and
- Perform water testing and raw material sampling and
- Perform QC testing for lot release, stability,
development/validation projects, and investigations
- Other functions include writing study protocols and
- Work with other departments in developing, revising and
implementing QC procedures and policies
- Should be aware of company cGMPs as well as industry
regulations that apply to all job functions
- Perform sample pick up and sample locating without supervision
and with strict adherence to written protocols
Position Type/Expected Hours of Work:
This role is a full-time, non-exempt position. Our "Flex Force"
team will work a 5 day a week schedule initially from 8am-5pm and
after 4-6 months of training, the team will transition to working
3pm-midnight. Because of the flexibility and important training,
the individuals in this team will have the opportunity to move to
our 4-day a week, 10-hour shift if they desire as openings
- BS degree in Biochemistry, Chemistry, Biology or a related
field and 2-4 years of biotech industry experience working in a QC
or analytical lab.
- Must have experience with analytical testing, writing reports,
GMPs, and regulatory audits.
- Candidate should also have experience with most if not all of
the methodologies listed above.
- Experience with basic maintenance and troubleshooting of
analytical instrumentation is highly desirable.
EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER
Avid Bioservices does not discriminate against any employee or
applicant for employment because of race, color, religion, sex,
national origin, age, marital status, genetic information,
disability or protected veteran status.
Keywords: Peregrine Pharmaceuticals, Inc., Tustin , In-Process Analyst, Quality Control (Flex Team), Other , Tustin, California
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