Raw Materials Inspector

General Information

Country United States

City Irvine, California

Functional Area Research & Development

Job Group Analytics

Employment Type Permanent Contract

Working time Full-time

The Siegfried Group is a global life science company with a network of 12 sites across Europe, the USA, and Asia. Siegfried offers contract development and manufacturing of active pharmaceutical ingredients, intermediates, and drug products. Siegfried has sales of 1.3 billion USD and employs over 3,600 people. Siegfried Holding AG is listed on the SIX Swiss Exchange (SIX: SFZN).

Our site in Irvine has been part of Siegfried since 2012 and counts around 150 employees. It is our sterile drug product manufacturing site in the US and provides cGMP sterile drug product fill and finish of biologics, suspensions, emulsions, ointments, and gels.

To support our lab, we are currently looking to fill the position of Raw Materials Inspector.

If you are looking to develop yourself within a dynamic team, this might just be the right opportunity for you.

Your role

The Raw Materials Inspector will be responsible for supporting raw material receipt, inspection, physical testing, and release in collaboration with various departments. This role involves participation in specification design using LIMS (Labware 7), conducting quality investigations, and performing physical testing using instrumentation. Additionally, the Raw Materials Inspector will ensure that raw materials meet internal specifications and are released timely for the manufacture of sterile drug products.

Your tasks:

• Independently execute QC inspection and testing to support routine manufacturing activities and new clinical/development products

• Perform sampling of raw materials for chemistry and microbiology testing in clean room classified areas, minimizing contamination using aseptic technique

• Collaborate with process transfer team to design raw material specifications for new materials and improve specifications for existing materials. Become proficient in use of Labware LIMS 7

• Perform inspection in compliance with relevant regulations. All activities are performed in GMP/GDP environment

• Assist in the performance of internal and external audits. Collaborate with purchasing, QA and the supplier to resolve issues with nonconforming batches of raw materials

• Attend production and project meetings as representative of the Raw Materials group to communicate status updates on pending raw material release

• Maintain the working areas in a clean and organized state. Assist in Quality oversight of warehouse operations

Your profile

• B.S. in Chemistry, Biology or other Pharmaceutical-relevant degree

• 3+ years of Experience in QC or QA

• 3+ years of Experience in FDA Regulated industry

• Experience performing Raw Material Inspection would be a plus

• Knowledge of quality systems, FDA and compendium requirements

• Familiarity with ANSI/ASQ sampling plans

• Positive team player in a fast-paced environment

Pay Range: $ 26 - 29 per hour

Working at Siegfried

• Medical, Dental, Vision

• Employer Sponsored Life & AD&D, Long & Short-Term Disability Insurance Plans

• Voluntary Life & AD&D, Accident and Critical Care Insurance Plans

• 401K Retirement Program with Matching

• Employee Referral Program

• Generous Paid Time Off, Sick Time and Paid Company Holidays

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