Country United States
City Pennsville, New Jersey
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
SUMMARY:
The incumbent assures compliance to all regulatory requirements, current Good Manufacturing Practices, and company Policies, Standard Operating Procedures and Work Instructions.
ESSENTIAL DUTIES, RESPONSIBILITIES AND ACCOUNTABILITIES:
- Reviews, approve and tracks executed production records.
- Reviews and approves production and QC investigations.
- Reviews lab sample results and manufacturing records related to qualification/validation activities.
- Conducts, write, and reviews quality related investigations as appropriate.
- Reviews and approves Master Production Records.
- Responsible for cGMP compliance of assigned manufacturing operations / areas.
- Completes QMS items as assigned.
- Is responsible for the conditional / final release of materials.
- Hosts customer and internal audits, as needed
- Conduct internal and external audits, as needed
- Participates in inspections by regulatory authorities
- Writes and reviews Annual Product Reviews/Product Quality Reviews
- Writes and reviews Product Validation / Qualification / Assessments documents.
- Writes and reviews Equipment Qualifications / Assessments documents.
- Writes and reviews Computerized Systems Validations / Assessments documents.
- Reviews, evaluates and approves minor equipment changes.
- Conducts GMP inspections.
- Conducts environmental monitoring.
- Reviews and approves CMC sections of DMFs as appropriate.
- Maintains QA databases for products / equipment as appropriate.
- Adheres to personal moral, ethical, legal, and behavioral conduct that is in compliance with the Siegfried Code of Conduct.
- Adheres to all applicable SHE and cGMP regulations e.g. ICH Q7, FDA, 21 CFR 210 and 211, etc.
Your profile
EDUCATION AND EXPERIENCE:
- A BA/BS degree in microbiology, biology, chemistry, or engineering and 3-5 years of experience in QA in a pharmaceutical manufacturing environment required, or an equivalent combination of education and experience.
- Thorough knowledge of cGMP in active pharmaceutical ingredient (API) manufacturing is preferable.
OTHER REQUIREMENTS:
- Must have excellent communication skills.
- Must be conscientious and detail oriented.
- Must have excellent computer skills (MS Office 365).
- Must be a team player.
- Must be able to self-manage daily work and set priorities.
- Must be able to manage projects and prioritize appropriately.
- Must be able to adhere to deadlines.
This position may be hired as a QA Specialist or Sr. QA Specialist, depending on the experience of the selected candidate. Our QA Specialist role carries a base salary of $78-85k with an at target 5% bonus. A Sr, QA Specialist has a base salary between $90-97k and a 5% at target incentive. Siegfried offers health, dental and vision coverage as well as life an disability insurance. Our 401k program offers a competitive match.
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 Pennsville
Pennsville is our drug substance manufacturing site for the US mar-ket and provides spray drying operations globally.
Main activities
- Pilot and commercial manufacturing of drug substances (APIs) and related intermediates
- All fully cGMP and SHE compliant
Features
- 3 GMP pilot suites: 0.1–2 m³ reactors
- 200m3 commercial capacity: 1–10 m³ reactors
- Successful transfer of new products to the commercial scale - Powerful rectification
- Spray drying in pilot and commercial scale for both isolation and dispersion technology
- Micronization in pilot and commercial
Strategic importance
- CMO for innovative drug substances and manufacturer of our opiates portfolio for the US market