6 QA Technician Jobs in Irvine, CA
Siegfried is Hiring a QA Technician Near Irvine, CA
Your role
This position supports the Quality Assurance Operation, which consists of QA Production Floor supports, and QA Product Release. This position is scheduled for 3rd shift,
Responsibilities
- Provide Quality support to Manufacturing personnel for compounding and in-process checks.
- Perform line clearance verification, sterilization chart review, scale calibration verification, and QA in-process checks including but not limited to visual inspection, CISIT/PID test, weight check, and torque test.
- Prepare in-process samples for submission to the Quality Control Laboratory.
- Support handling of GMP events and initiation of deviation investigations.
- Read, understand, and follow SOP’s and complies with cGMP.
- Support the issuance of GMP documentation to Manufacturing floor.
- Review executed batch records for completeness, accuracy and compliance with Good Documentation Practices.
- Use computerized system such as SAP, LIMS, and TrackWise for data collection and batch record review.
- Scan and file batch records (physically & electronically).
- Perform other work-related duties as assigned by management.
Required Knowledge, Skills And Abilities
- Good computer skills
- Strong attention to detail
- Good oral and written communication skills
- Ability to work overtime and/or work occasionally on weekend as needed
- General high school degree/GED or equivalent required.
- Some college or technical college preferred.
- Prior experience working in QA function preferred.
- Basic reading, writing, and math skills required.
- 1-2 years' experience working in a Pharmaceutical, Medical Device, or other FDA regulated industries required.
Working at Siegfried
Siegfried's work environment is dynamic and international. With a highly professional and motivated team, the company operates in a future-oriented business field. Siegfried possesses a unique culture that leverages cultural differences to create a competitive advantage. Siegfried places highest priority on providing a flexible, diverse and discrimination-free working environment in which employees can develop personally and professionally, advance innovation and deliver superior performance. We strive to provide a work environment where employees can take on challenging jobs and associated responsibilities that best serve their personal and technical development and can benefit from the success of our company. The company regulations in respect of compensation and career development opportunities apply to all Siegfried sites. Additional conditions of employment are governed by location-specific circumstances, legislation and customs.
Who we are
In the Midst of People’s Lives – Across the Globe The Siegfried Group is one of the world’s leading Custom Development and Manufacturing Organizations (CDMOs) developing and producing active pharmaceutical ingredients (API), intermediates and finished dosage forms. As our core competence, we successfully integrate chemical and pharmaceutical capabilities into a single business model. The Siegfried name stands for highest quality, efficiency, flexibility and safety. Present in Europe, Asia and North America, we serve a broad global customer base from major international pharmaceutical companies down to small biologic-pharmaceutical organizations. For them we develop and produce product innovations on a large scale to finished products. We integrate our offer seamlessly into the customers’ value chain. Our comprehensive services range from early-stage Research & Development services such as synthesis, scale-up, formulation development, stability studies and method development all the way through to manufacturing services, ranging from preclinical R&D material for clinical trial purposes to commercial production. We are able to produce about 200 of the approximately 1500 registered drug substances used in medicine. Moreover, we produce 20 percent of global demand for caffeine. Consequently, nearly 1 billion individuals come into contact with Siegfried products.
What we do in Irvine
Irvine is one of Siegfried’s sterile drug product manufacturing sites, providing contract development and manufacturing services (CDMO) specializing in difficult to manufacture pharmaceuticals, ophthalmics, and drug delivery devices.
Main activities
- Provides cGMP sterile drug product fill finish of biologics, suspensions, emulsions, ointments, and gels
- All fully cGMP and SHE compliant
- Commercial Products: 5 automated filling lines, Commercial manufacturing, Batch sizes up to 150 K units, Fill Volumes 0.5 ml – 100 ml
- Semi-automated and automated visual inspection
- Automated packaging with digital data visual verification
- Stability study services
- Drug delivery
- Laboratory services
- Clinical Products small lot capability (semi-automated filling, batch sizes up to 5 K units)
- Clinical manufacturing (batch sizes less than 5 K units)
- CDMO for innovative and difficult-to-manufacture products from clinical to commercial NDA and ANDA products
- Provides contract sterile drug product manufacturing and laboratory services to the pharmaceutical and biotechnology industries
Job Summary
Full Time
$105k-126k (estimate)
07/03/2024
08/04/2024
lawyerstlouis.com
Mo
<25
Related Companies
The job skills required for QA Technician include Quality Assurance, Quality Control, Packaging, Written Communication, Calibration, Attention to Detail, etc. Having related job skills and expertise will give you an advantage when applying to be a QA Technician. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by QA Technician. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for QA Technician positions, which can be used as a reference in future career path planning. As a QA Technician, it can be promoted into senior positions as a Quality Assurance Specialist IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary QA Technician. You can explore the career advancement for a QA Technician below and select your interested title to get hiring information.
If you are interested in becoming a QA Technician, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a QA Technician for your reference.
Step 1: Understand the job description and responsibilities of an Accountant.
Quotes from people on QA Technician job description and responsibilities
A quality assurance technician does monitors the production process and product by sensory, weight control, and analytical methods to maintain product consistency and comply with established specifications including color, moisture, pH, weight, size, etc.
03/02/2022: Baton Rouge, LA
Some technicians look at every product that comes off the assembly line, while others perform spot checks.
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Monitors the Food Safety Plan and Food Quality Plan effectiveness and conformance with SQF system requirements
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Quality technicians test and report on the quality of products.
02/06/2022: Jacksonville, FL
Quality control technicians are also responsible for reporting on their findings and for keeping careful logs of what they observe.
03/31/2022: Albany, GA
Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
Career tips from people on QA Technician jobs
QA Tech must have a comprehensive understanding of your company.
01/08/2022: Kingsport, TN
They need to be intimately familiar with your processes, your values, and your goals.
02/13/2022: Danbury, CT
Pay attention to detail in executing checks. Be enthusiastic quality advocate.
03/08/2022: Fort Wayne, IN
You should understand the work that others in your department do and how it impacts your own.
02/04/2022: Fort Lauderdale, FL
To become a successful QA technician you need to be able to manage multiple priorities & meet deadlines.
03/29/2022: Casper, WY
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