Title: Quality Assurance Associate
Duration: 12 Months
Location: 100% remote (ok to be hybrid if located near a client site)
 
Job Description:
The purpose of the Quality Assurance Associate role is to operate a local Quality system in the territory of responsibility.
Full compliance with all local requirements and company policies, and to represent clients’ Quality within a specific country.
 
QA (Quality Assurance) Support QA activities:

• Supports the implementation of the Local Quality Management System (QMS) in compliance with local regulations and client standards.
• Enforces the quality management system in all the quality activities of the affiliate.
• The quality activities include but are not limited to batch release, change control, product complaint, and deviation management.
• Provides 3PL vendor oversight and supports qualification, selection, and negotiation of new suppliers.
• Supports new product launches and ensures compliance with the existing lifecycle products.
• Acts as the secondary point of contact to the LQO to report or liaise about any recalls, field actions, or quality-related supply chain issues with batches delivered to the affiliate or region not meeting requirements.
• Local engagement, Cross-functional engagement.
• Serves as deputy for Local/Regional Regulatory Affairs and Local/Regional Pharmacovigilance as assigned and where applicable according to local regulation.

Maintains the Quality Management System in compliance with local regulations and CLIENT standards, including but not limited to:

• Deviation Management.
• Corrective Action & Preventive Action (CAPA) Management.
• Product Complaints Management.
• Change Control Management.
• Documentation Management.
• Training Management.
• Recall Management.
• Self-Inspection Management.
• Quality Risk Management. 

Implements the Quality Management Systems in daily operations:

• Responsible for remaining compliant for all Quality CLIENT products licensed, marketed, or supplied within the Territory of responsibility.
• Responsible for staying compliant with local as well as international regulations and maintaining inspection readiness.
• Oversees the legal documentation required to maintain compliance with the assigned Territory, Market or Region.
• Maintains up-to-date Quality Agreements.
• Implements and maintains local Quality procedural documentation (in accordance with Global policies
• and procedures and the local document management system).
• Monitors performance indicators
• Resolves quality-related issues.
• Archives and maintains all quality documents in line with CLIENT procedures and legal requirements.
• Self-inspections & Quality Audits Management.
• Supports and participates in corporate organization audits and assists in audit preparation activities, including the development of CAPA plans and the close-out of any audit action items.
• Product Recalls & Field actions Management.
• Acts as Affiliate Recall Coordinator and promptly performs any recall operations for all CLIENT distributed products according to CLIENT procedures and local regulations.
• Coordinates with marketing authorization holders and national competent authorities in the event of recalls.
• Supports as required in the event of a field action, as determined by the Supply Chain Incident Management Team (SCIMT).
• Product Returns Management.
• Ensures product returns are managed efficiently.
• Responsible for processing products based on the final disposition of returned products.
• Verification of Suppliers and Customer Status.
• Ensures that only qualified GMP/GDP-relevant suppliers, vendors, and customers are used.
• Management of Unlicensed Products.
• Ensures that any additional requirements imposed on certain products by national/regional law are adhered to, e.g., specials, unlicensed imports.
• Final administrative release of all product batches.
• Ensures all batch documentation and transportation documents are available and compliant with local/regional requirements to make a final decision on whether or not to release in SAP.
• Contact with Local Regulatory Agency.
• Acts as deputy to the LQO/RQO contact point to report or liaise with distributors if any quality-related issues arise supply chain issues with batches delivered to the Affiliate/region as not meeting the requested quality criteria.

Minimum Requirements:

• Degree in pharmacy or life science (if required by local legislation) or equivalent experience.
• At least 1 year of experience in the pharmaceutical industry.
• At least 1 year of experience in Quality Management Systems.
• Understands and has experience in pharmaceutical quality assurance systems.
• Knowledge of Good Distribution Practices (GDP), Good Manufacturing Practices (GMP), and local regulations and guidelines as applicable to the level of activities carried out at the affiliate or region.
• Fluent in local or regional languages and good knowledge of oral and written English (preferably native English speaking).
• Sound and balanced judgment; able to assess and handle risks; self-confident, proactive, and decisive.
• Works and communicates effectively and collaboratively across affiliate functions and other global clients’ functions and external partners or third parties.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 22.00/hr.