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

• 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).

Responsibilities

• 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.

Your Profile

• 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.

Job Type: Full-time

Pay: $65,000.00 - $75,000.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 3 years

Schedule:

• Monday to Friday

Work setting:

• In-person
• Manufacturing facility

Work Location: In person