Supervisor, Quality Control- Finished Product

General Information

Country United States

City Pennsville, New Jersey

Functional Area Research & Development

Job Group Quality Control

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 demonstrates proficiency through a wide exposure to pharmaceutical analyses and has a firm grasp of scientific principles and skill in applying this knowledge. The incumbent has practical experience in pharmaceutical analyses and routinely performs analysis in the functional areas of HPLC, GC, and Wet Chemistry. The incumbent performs and trains on routine chromatographic analyses. The incumbent supervises and manages up to 5 direct reports.

ESSENTIAL DUTIES AND RESPONSIBILITIES :

• Supervises and manages the QC Finished Product team.
• Supervises daily activities in the QC laboratory, including sampling, testing, and documentation.
• Schedules / assigns work to direct reports.
• Performs analytical / wet chemistry testing on raw materials, final dryers, and finished lots approximately 50% of the time.
• Sends samples out to external testing laboratories when needed.
• Provides analytical / wet chemistry support for production.
• Ensures all analytical testing (HPLC, GC, FTIR, UV, KF, etc.) is conducted as per validated testing methods and regulatory standards.
• Ensures proper handling and disposal of chemicals, reagents and hazardous materials.
• Responsible for investigating DEA related issues in the QC Lab.
• Review and approves analytical data and test reports.
• Initiates and authors OOS / OOT investigations, lab events, and deviations in conjunction with the QC Manager / Director.
• Supports and participates in internal and external audits by preparing and providing the necessary documentation. Addresses compliance gaps as needed.
• Supports Analytical and Chemical Development by testing / scheduling sample analyses.
• Reviews / approves change controls for method updates via Trackwise and LabWare.
• Assists in writing of SOPs, testing standards, protocols and reports.
• Assists in SOP / documentation updates, CAPA closures, and remediation plans.
• Assists in training of lab personnel on instrumentation, methods, and cGMP.
• Shares in the responsibilities of housekeeping (i.e. Glassware, waste, retains, etc.).
• Provides ideas / feedback for areas where efficiency can improve.
• Reviews and releases analytical results.
• Performs any other laboratory tasks deemed necessary by the QC Manager / Director.
• Adheres to personal moral, ethical, legal, and behavioral conduct that follows the Siegfried Code of Conduct.
• Adheres to all applicable SHE and cGMP regulations.
• Performs all tasks in accordance with cGMP compliance.

SUPERVISION :

Your profile

EDUCATION AND EXPERIENCE :

OTHER REQUIREMENTS :

Siegfried USA will explore and provide reasonable accommodations to assist any qualified individual with a disability in performing the essential functions of his / her job. Please speak with HR should you require an accommodation or have any questions.

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

Back to job list