Quality Assurance Specialist

Datwyler•Pennsauken, NJ

9d•Hybrid

About The Position

This position 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 state-of-the-art, clean, pharma packaging manufacturing environment.

Requirements

Bachelor’s/Master’s Degree preferred.
3-5 years of relevant work experience in a QA role.
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.

Nice To Haves

Experience with classified areas is preferred.
Experience in customer-facing role desirable.

Responsibilities

Support the site in order to guarantee continuity of Quality systems and activities according to global and local standards and at acceptable cost.
Partnering with operations to support site objectives.
Find global balance between quality requirements, compliance and costs.
Manage and maintain the Quality Management System: ensure the compliant status of the QMS with the requirements of ISO 9001.
Provide interdepartmental assistance to ensure that controlled documents reflect current practice.
Ensure proper document distribution and continually improve the flow of the documentation process.
Supports customer complaints, internal quality notifications, change control process, the CAPA process, and supports the investigations related to complaints and Nonconformances.
Define and implement quality related projects with the aim to significantly improve the Quality and or compliance level.
Liaise with relevant groups on site (e.g. operations, supply chain, engineering, etc.) and cooperate to come to a timely resolution of the mentioned QA processes.
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).
Manages/conducts training of Internal Auditors for the site (annually)
Completes preparation for external audits (including ISO certification)
Supports preparation for EHS certification (140001 and 450001)
Ensure the continuity and the compliance of the site’s Quality Management System according to global and local standards (e.g. ISO 9001/15378, global group Quality procedures) and at acceptable cost.
Provide interdepartmental assistance to ensure that controlled documents reflect current practice.
Ensure proper document distribution and continually improve the flow of the documentation process.
Support customer complaints, including support of the investigation with the relevant departments in the site.
Support the local change control process.
Define and implement quality related projects with the aim to significantly improve the Quality and/or compliance level.
Partnering with operations to support site objectives.
Find a good balance between quality requirements, compliance and costs.