- Leads the investigations related to customer complaints, internal events and deviations and communicates on the outcome (either to customer or internally).
- Manages the change control and CAPA processes.
- Liaise and cooperate with relevant groups on site (e.g. operations, supply chain, engineering, etc.) to come to a timely resolution of the mentioned quality processes
- Define and implement quality related projects with the aim to significantly improve the Quality and/or compliance level.
- Support the site and the quality management to achieve site objectives and to guarantee continuity and compliance of Quality systems and activities according to global and local standards.
- Support for internal and external audit performance (customers, regulatory agencies, ISO and suppliers) and follow up of the outcome (e.g. audit report, corrective actions, replies to external auditors and customers).
- Quality Support to Project Management with regard to the SUSP site. Examples: GCR to LCR, implementation of new raw materials, customer communications, QA reviews, provide follow up information requested, etc.
- Provide acknowledgement to customer. Organize and conduct complaint investigations. Provide written response to customer and distribution. Provide follow-up to customer as needed.
- Organize quality assurance functions, including internal/external deviations and local change requests (LCRs). Provide support and direction to departments. Organize monthly CAPA and LCR update meetings toward reduction of overdue actions.
- Compile KPI data with necessary department managers, draft annual management review document, set up meetings for review and approval of Management Review. Overhaul the Change Management process to minimize gaps and train the site on the updated process for implementation. Lead multiple internal audits through completion and support in the training of new internal auditors.
- Bachelor's Degree preferred. Science or engineering-related field a plus.
- 3-5 years of relevant work experience in a QA role.
- Experience with classified area's is preferred.
- Thorough knowledge of cGMP regulations and current industry practice.
- Knowledge of ISO 9001 and ISO 15378.
- Good knowledge of domain-specific legislation, relevant standards and procedures.
- Fluent in English, both verbal and written.
- Experience in customer-facing role desirable.
- Medical Benefits – eligible on 1st day of employment
- Dental Benefits
- Vision Benefits
- 401(k) retirement program
- Company paid Term Life and Accidental Death & Dismemberment
- Option to purchase additional Life insurance
- Short / Long Term Disability
- Identity Theft Assistance
- Will Preparation Services
- Paid Time off (vacation)
- Paid Time off (sick)
- Twelve (12) paid holiday
- Flexible Spending Accounts
- Employee Assistance Program
-
Quality Assurance Specialist
1 week ago
Antithesis Foods Inc. Philadelphia, United StatesPosition: QA & Compliance Specialist · Company: Antithesis Foods, Inc. · Location: Philadelphia, PA · Company Mission: · We are a food company making processed foods healthier using the best food science. Our goal is to make eating healthier, more accessible, more affordable, and ...
-
Senior Quality Assurance Specialist
4 days ago
Mondo Camden, United StatesJob Title: Senior QA · Location-Type: Hybrid-Camden, NJ · Start Date Is: 2 weeks from offer · Duration: W2 contract · Compensation Range: $40-$49/hr · Job Description: · Our client, a leading automotive brand, is seeking a Senior QA Consultant for their office in Camden, NJ. This ...
-
Veeva Quality Assurance Specialist
1 week ago
University of Pennsylvania Philadelphia, United StatesUniversity Overview · The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World ...
-
Veeva Quality Assurance Specialist
1 week ago
Trustees of University of Pennsylvania Philadelphia, United States Full timeDescription · Job Responsibilities · The Abramson Cancer Center (ACC) of the University of Pennsylvania is a world leader in developing and conducting innovative clinical trials for the prevention, diagnosis, and treatment of cancer. The ACC Clinical Research Unit (CRU) is ins ...
-
Senior Sterility Assurance Specialist
4 days ago
R&D Partners Philadelphia, United StatesJob Description · Job DescriptionEssential Functions and Responsibilities · Championing sterility assurance principals at the site in the areas of aseptic processing, and contamination control. · Support the site compliance to the global microbial control standards/procedures on ...
-
Data Intelligence Philadelphia, United StatesData Intelligence, LLC (DI) is searching for a full time Information Assurance Compliance Specialist II (RMF Specialist) in Philadelphia, PA. This is an on-site position at NSWC Philadelphia. · Job Responsibilities · Implement and review RMF and A&A lifecycle documentation in a ...
-
WuXi AppTec Philadelphia, United StatesOverview · Primary resource for the development, execution, review, and approval of equipment/software validations (including Computerized Laboratory Systems), System Life Cycle Documentation (Validation Plans, Design Specifications, Requirements Specifications, etc.), Change Con ...
-
WuXi AppTec Philadelphia, United StatesOverview: · Primary resource for the development, execution, review, and approval of equipment/software validations (including Computerized Laboratory Systems), System Life Cycle Documentation (Validation Plans, Design Specifications, Requirements Specifications, etc.), Change C ...
-
WuXi AppTec Philadelphia, United States**Overview** · Primary resource for the development, execution, review, and approval of equipment/software validations (including Computerized Laboratory Systems), System Life Cycle Documentation (Validation Plans, Design Specifications, Requirements Specifications, etc.), Change ...
-
Purchasing Specialist
4 days ago
Beyond a Resume Cherry Hill, United StatesBeyond A Resume seeks a Purchasing Specialist for our biotech client in Millville, NJ. · **Job Overview**: · The Purchasing Specialist is responsible for sourcing contract manufacturers, ingredients vendors, packaging materials vendors and production materials; Conducting RFPs to ...
-
Procurement Specialist
1 week ago
Beyond a Resume Cherry Hill, United StatesBeyond A Resume seeks a Procurement Specialist for our biotech client in Millville, NJ. · **Job Overview**: · The Procurement Specialist is responsible for sourcing contract manufacturers, ingredients vendors, packaging materials vendors and production materials; Conducting RFPs ...
-
Purchasing Specialist
1 week ago
Beyond a Resume Cherry Hill, United StatesBeyond A Resume seeks a Purchasing Specialist for our biotech client in Millville, NJ. · **Job Overview**: · The Purchasing Specialist is responsible for sourcing contract manufacturers, ingredients vendors, packaging materials vendors and production materials; Conducting RFPs to ...
-
Adaptimmune Philadelphia, United StatesAdaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T ...
-
Revenue Assurance Specialist
1 week ago
Cantaloupe Inc. Malvern, United StatesRevenue Assurance Specialist · Help the world buy it and go · Cantaloupe, Inc., is a FinTech company that is constantly evolving the way companies worldwide manage, optimize, and automate the critical decisions made daily. We are committed to helping businesses grow smarter, bett ...
-
Adaptimmune Philadelphia, United States Full timeThe Sr. Quality Assurance Specialist will be responsible for supporting quality functions such as line clearance, batch record review, label issuance, raw material release and facilitating timely release of production lots. The successful candidate will work closely with other Qu ...
-
Revenue Assurance Specialist
4 days ago
Cantaloupe,Inc. Malvern, United StatesJob Description · Job DescriptionRevenue Assurance Specialist · Help the world buy it and go · Cantaloupe, Inc., is a FinTech company that is constantly evolving the way companies worldwide manage, optimize, and automate the critical decisions made daily. We are committed to help ...
-
Adaptimmune Philadelphia, United StatesJob Description · Job DescriptionAdaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell plat ...
-
Quality Assurance Specialist
4 days ago
Astrix Ambler, United StatesOur pharmaceutical client is seeking a Quality Specialist to join their team. The ideal candidate will have a scientific background with quality experience. · Location: Ambler, PA · Pay: $28-$32 per hour · Type: Contract · Responsibilities · Execute relevant procedures to ensure ...
-
Quality Assurance Specialist
1 week ago
Eurofins West Point, United States Full timeCompany Description · Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to th ...
-
Quality Assurance Specialist
4 days ago
TCG GreenChem Inc Trenton, United StatesJob Description · Job DescriptionJob Summary · Leadership responsibility to manage quality assurance and compliance programs and business excellence efforts at TCG GreenChem. Represent as in house worldwide expert in cGMP regulations and understanding phase appropriate developmen ...
Quality Assurance Specialist - Pennsauken, United States - Datwyler
Description
In billions of syringes and in every second car worldwide, Datwyler components make an important contribution to the safety of patients and drivers. The high-tech company focuses on high-quality, system-critical elastomer components and holds leading positions in attractive global markets such as healthcare, mobility, connectivity, general industry and food & beverage. With over 25 production sites on four continents, sales in more than 100 countries and over 8,000 employees, the company, headquartered in Switzerland, generates annual sales of more than CHF 1,000 million.
Our employees are the heart of Datwyler - we treat each other with respect, trust and appreciation. We have strong roots and values that have been well established in our 100-year corporate history. Become part of our great team as a...
Position Summary
The Quality Assurance Specialist handles the quality requirements and standards for manufacturing products in a GMP-regulated environment. Being a hands-on person, the incumbent of this position will support the site quality system and procedures in alignment with the global group quality policies and applicable industry standards.
The responsibilities will be focused on the operations of a clean, pharma packaging manufacturing environment.
Essential Functions
Responsibilities
Your Profile
Our Offer to you
At Datwyler Sealing Solutions we are committed to a comprehensive employee benefit program that helps our employees stay healthy, feel secure and maintain a work/life balance.
Stay Healthy
Feeling Secure
Work/Life Balance
Be yourself at Datwyler
We are convinced that people make the difference. At Datwyler, you will experience diversity and a wide range of career opportunities that only an international company can provide. Together, we are increasing our agility, accelerating digitalization and fostering sustainability. For motivated and talented employees, we offer interesting development opportunities with training and assignments in a global environment. With us, you can contribute with all of your creativity and all your ideas.