Sr. Quality Assurance Specialist

General Information

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 :

OTHER REQUIREMENTS :

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

Features

Strategic importance