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
The Quality Specialist, Quality Systems & Compliance will provide and apply sound GMP based critical thinking in support of the Quality mission at Siegfried Irvine with particular focus on supplier qualification and site internal compliance.
Responsibilities
1. Administration of the site Supplier Qualification Program, including but not limited to management of qualification status, initiation and tracking of annual qualification schedule, execution of qualification activities, and management of physical and electronic qualification records.
2. Monitoring of internal compliance, including but not limited to administration and execution of the Internal Audit Program, management of external standards library, and reporting of conformance to compliance targets.
3. Supporting the preparation and hosting efforts of customer, corporate, and regulatory audits including document and SME preparation..
4. Assist site Regulatory Affairs expert with customer requests regarding regulatory submissions.
5. Assist and support in the Quality assessment, review, and/or approval of other QAD and Compliance areas of responsibility such as change control (including document changes), investigations, training administration, and logbook management.
6. Provide training, guidance, and sound GMP advisement to other team members and departments as needed
7. Any and all other duties as assigned by immediate supervisor.
Your profile
Required Knowledge, Skills and Abilities
- Auditing with high level understanding of GMP and applicable regulations (e.g., ISO, EU) at an academic, technical, tactical, and conceptual level
- Good oral and written communication skills
- Technical and formal/business writing
- High computer literacy with particular focus on Windows platform and Office applications (Word, Excel, PowerPoint); experience with eQMS such as TrackWise or MasterControl is a plus
- Strong organizational abilities
Required Education and Experience
- Bachelor’s Degree in a scientific field or equivalent combination of education and experience
- 7 years' experience in the pharmaceutical, medical device, or biotech industry
- 4 years in experience in a Quality role
Target Range: $70,000 - 80,000
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