Vacancy Number: req2693

Location: Mill Hall

Location Address:
8 Croda Way, Mill Hall
Mill Hall, Pennsylvania, PA 17751
United States

CRODA

Smart science to improve lives ™

Be part of our journey

As a global leader in specialty chemicals, we continue to succeed and strengthen our delivery of innovative, sustainable, and high-performance solutions. We are passionate and excited about how we can develop and utilize new technologies to shape and inspire changes within an ever-growing marketplace.

Our ideal person

As a business, it is really important to us that we find the best person for the job and that you have the best opportunity to succeed in the role. To help, we have outlined our expectations for the role and what core skills and experiences we require as well as what would make you an ideal fit. In turn, we hope this helps you evaluate if this is the right job for you.

Quality Management Systems Specialist – Training and Regulatory

Overall Description:

Croda is seeking an Quality Management Systems Specialist – Training & Regulatory that will complete, support, and monitor aspects of quality management systems including support for maintaining certification to ISO 9001, EFfCI and EXCiPACT quality management systems, as well as adherence to applicable aspects of cGMPs. Performs all duties within the Company’s safety, health and environmental regulations. All other duties as assigned by management.

Key Job Responsibilities:

Training Management System (50%)

Management of training management system in Intelex including registering new training, maintaining training matricies, conducting training, support for course revision activites, releasing scheduled courses, obsoleting training as needed, recording past session training data, and providing training management system reports.

QMS Support (10%)

QMS training and training support.

Participate in GMP compliance activities such as GMP walks.

Data collection for QMS annual management review.

Participation in analysis of data efforts.

Review of Product Information (20%)

Assimilate and interpret large amounts of data (products, manufacturing processes, businesses, regulations, etc.) and suggest improved and more efficient methods of working

Preparation and review of GMP documentation related to product reviews

Ensure records are kept in accordance with legal requirements as well as Croda internal requirements

Entry of product reviews in Intelex audit application, assignment of response tasks

Auditing Support (20%)

Experience / Education Required:

2 years’ experience with ISO 9001/cGMP/FDA compliance within a GMP manufacturing environment. 2-3 years specialty chemical experience including a strong technical background. Experience with training system execution a plus. Must have a good working knowledge relating to chemical use in the United States, a knowledge of the regulatory environment in North America and elsewhere is preferred but not required. Must be able to work under tight deadlines and maintain relationships with numerous individuals in multiple departments. Must be able to prioritize own work and work independent of supervision. Must have good problem solving and critical thinking skills. Proficient with Microsoft office programs, experience with SAP desired.

Education / specialized training required:

BA or BS in Chemistry or related field. Education/training in cGMP. Excellent written and oral communications skills, including the ability to take complex product information and formulate suitable customer responses in the form of statements and reports. Must have oral and written proficiency in the English language.

Croda recognizes employees as our strength and the diversity they bring to our workforce are directly linked to our ongoing success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. We do not discriminate on the basis of any protected attribute, including age, race, color, religion, national origin, gender, sexual orientation, gender identity, gender expression, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. In accordance with applicable law, we make reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as any mental health or physical disability needs.

Equal Opportunity Employer/Disability/Veterans. This Organization Participates in E-Verify