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
The QA Training & Documentation Specialist will support the QA Department with all Training and Document Control duties.
Responsibilities:
1. Ensure GMP/ISO compliance in all documentation control activities to meet customer's expectation based on Quality Management System (QMS) requirements.
2. Administrate the local Training System according to site, corporate, and regulatory standards to include: building of required system assets (e.g., training materials, classes, curricula) based on input from the different department management, technical and administrative support to users, processing of completed trainings, management of training records, organization / execution of site training objectives and requirements (e.g., Annual GMP Training), and monitor / report training status.
3. Assist in the administration of Document Control / Document Management System according to site, corporate and regulatory standards to include: processing of document revisions/implementations, periodic review of documents, retrieval and archiving of documents, and security of physical document storage and electronic copies
4. Assist in the management of the Document Control area to ensure security and availability of materials and supplies to accomplish the Document Control mission
5. Assist in the management of the logbook program ensuring timely issuance and reconciliation of logbooks
6. Assist in the maintenance and execute of the filing system for the manufacturing documentation, to include: issuance of batch records, archival of executed batch records, and return of customer owned documents
7. Provide sound Quality guidance and enforcement of Document Control and Training procedures and fundamentals
8. Provide training on Document Control owned and Training systems.
9. Support the Quality Unit during customer and regulatory audits and inspections
10. Any and all other duties as assigned by immediate supervisor.
Your profile
Required Knowledge, Skills and Abilities
- Understanding of GMP at an academic and conceptual level and adherence at a tactical level
- Understanding of training fundamentals for effectiveness and compliance
- Understanding of document control fundamentals
- Customer service with focus on order and request fulfillment
- Strong organizational, records/database management, and area housekeeping skills
- Good computer literacy with particular focus on Windows platform and applications such as Adobe and Office (Word, Excel)
- Good oral and written business communication
- Public Speaking
- Ability to lift 15 to 25 lbs.
Required Education and Experience
- Bachelor’s Degree or equivalent combination of education and experience
- 4 years working in a Quality role in a GMP environment / 8 years if previous experience is non-Quality role
Target Salary Range: $75,000-85,000
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