General Information

Country United States

City Irvine, California

Functional Area Operations

Job Group Quality Assurance

Employment Type Permanent Contract

Working time Full-time

At its locations around the world, Siegfried offers employees exciting career opportunities in international settings. We cultivate multidisciplinary cooperation and encourage our staff to actively shape and influence their careers. This approach, coupled with our dynamic working environment, make Siegfried an attractive employer.

Your role

Scope and Purpose of Position

This position supports the Quality Assurance Operation, which consists of QA shop floor supports, and QA batch review and Product Release.


Responsibilities


  1. QA Production Floor Support


    1. Provide Quality support to Manufacturing personnel on the shop floor for compounding and QA- in-process checks.

    2. Perform line clearance verification, sterilization chart review, scale calibration verification, and QA in-process checks including but not limited to visual inspection, CSIT/PID test, weight check, and torque test.

    3. Perform AQL and Level II Visual Inspection for Finished products.

    4. Prepare in-process samples for submission to the Quality Control laboratory.

    5. Support handling of GMP events and initiation of deviation investigations.

    6. Read, understand, and follow SOP’s and comply with cGMP and GDP.

    7. Support the issuance of GMP documentation to the Manufacturing floor.

    8. Perform other work-related duties as assigned by management.

  1. QA Batch Review and Product Release

    1. Review executed batch records for completeness, accuracy and compliance with approved procedures and Good Documentation Practices (GDP) and resolve discrepancies with manufacturing operators or supervisors.

    2. Use computerized systems and software such as SAP, LIMS, and TrackWise for data collection and batch record review.

    3. Enter and verify data from executed batch records into the Product Log Sheet and maintain the database up to date at all times.

    4. Participate in deviation investigation and CAPA implementation.

    5. Initiate Certificate of Conformance and prepare executed batch records for product release in a timely manner to meet compliance requirements and business needs.

    6. Scan and file batch records (physically & electronically).

    7. Assist in writing and/or revising SOPs to ensure compliance with cGMP and other applicable regulations.

    8. Perform other work-related duties as assigned by management.

Your profile

Required Knowledge, Skills and Abilities


  • Working knowledge of QA principles In Pharmaceutical and/or other FDA regulated industries required

  • 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


Required Education and Experience


  • BS degree in Biochemistry, Chemistry, Engineering, Biology or closely related discipline required

  • 1-2 years' experience in Quality Assurance / Manufacturing environment in Pharmaceutical or other GMP regulated industries required

Target Pay Range: $31-34/hour

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

Features

  • 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)

Strategic importance

  • 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

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