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About the Role

The Quality Assurance Associate participates in milestone completion for specific projects and supports Annual Product Reviews, Deviation Management, CAPA, Change Management, SOP Management, and general quality management systems responsibilities for commercial product manufacturing, packaging, and release.

Responsibilities

• Completes APR reports by gathering information from batch records, investigations, product changes, and complaints.
• Collaborates with business units to review and manage Change Control Requests, ensuring adherence to GDP and change management procedures.
• Monitors internal QMS compliance through audits of production, facilities, validation, and laboratories.
• Identifies areas for continuous improvement within the QMS in collaboration with Quality colleagues.
• Acts as a Subject Matter Expert (SME) for Investigations & Quality Risk Management.
• Reviews deviation and investigation records, including tracking, follow-up, and reporting/trending, ensuring adherence to GDP and deviation procedures.
• Reviews Corrective and Preventative Actions (CAPA), including tracking, follow-up, reporting/trending, and evaluating CAPA effectiveness.
• Guides the timely completion of Deviations, CAPA, Corrective Work Orders, Change Controls, and Investigations with all departments.
• Assists the Compliance Specialist with batch record review for product release.
• Generates and maintains Quality Assurance and QMS standard operating procedures (SOPs).
• Oversees controlled document and system changes, performing detailed impact analysis to ensure all necessary GMP and qualification action items are included and executed within change controls.
• Collaborates significantly with cross-functional groups, including Quality Assurance, Manufacturing, Process Development, Facilities, and Regulatory Affairs on quality assurance matters.
• Cross-trains with other QA Associates.
• Manages logbook issuance, control, and review.
• Files and maintains controlled documents.
• Performs other duties as assigned.

Requirements

• Minimum 5 years of GMP-related experience in biopharmaceutical or pharmaceutical manufacturing.
• Proven ability to prioritize tasks and meet internal and external customer needs in a fast-paced environment.
• Experience supporting Quality projects, including data analysis and evaluation of identifiable factors.

Skills

• Strong knowledge of cGMP/GDP requirements
• Strong knowledge of international regulatory compliance
• Strong knowledge of GMP operations

Experience Level

• Minimum 5 years of GMP-related experience

Education Level

• Bachelor's degree or diploma in Chemistry, Biology, Engineering, or a related field.

Benefits

• Gym Access
• Dental insurance
• Health insurance

About the Company

• Apollo Health & Beauty Care Ltd. will ensure accommodations are available in consultation with candidates during all stages of the recruitment process.
• Apollo is committed to providing accommodations for people with disabilities in all parts of the hiring process.
• Apollo will work with applicants to meet accommodation needs that are made known in advance.
• We thank all applicants for their interest however only those meeting the minimum qualifications will be interviewed.
• This posting represents an existing vacancy, and we are actively recruiting to fill this position.

Equal Opportunity

• Apollo Health & Beauty Care Ltd. will ensure accommodations are available in consultation with candidates during all stages of the recruitment process.
• Apollo is committed to providing accommodations for people with disabilities in all parts of the hiring process.
• Apollo will work with applicants to meet accommodation needs that are made known in advance.