Quality Assurance Associate

Job summary

The Quality Assurance Associate manages QMS responsibilities including deviations, CAPAs, change management, and SOPs to support commercial product release. They also perform internal audits and act as a Subject Matter Expert for investigations and quality risk management.

Job details

Benefits: Gym Access Dental insurance Health insurance We're Hiring! The Quality Assurance Associate participates in the completion of milestones associated with specific projects and supports ongoing Annual Product Reviews, Management of Deviations, CAPAs, Change Management, SOP Management, and general quality management systems responsibilities in support of the manufacture, packaging and release of commercial products. JOB RESPONSIBILITIES Completes APR reports in accordance with the schedule, gathering information available from batch records, investigations, product changes, complaints etc. Collaborate and liaise with business to review and manage Change Control Requests. Ensures GDP and change management procedures are followed. Assists with monitoring all internal QMS compliance through performing internal audits, including production, facilities, validation, and the laboratories. In collaboration with Quality colleagues identifies areas for continuous improvement within the QMS. Acts as Subject Matter Expert (SME) for Investigations & Quality Risk Management. Reviews deviation and investigation records, includes tracking, follow-up, and reporting/trending. Ensures GDP and deviation procedures are followed. Reviews Corrective and Preventative Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness. Works with all departments to guide the timely completion of Deviations, CAPA, Corrective Work Orders, Change Controls, and Investigations. Helps the Compliance Specialist with the review of batch records for product release. Generates and maintains Quality Assurance and QMS standard operating procedures (SOPs). Oversees controlled document and system changes and performs detailed impact analysis to ensure all necessary GMP and qualification action items have been added to the change controls, as well as executed. Collaborates significantly with cross functional groups, including Quality Assurance, Manufacturing, Process Development, Facilities, and Regulatory Affairs on quality assurance matters. Cross-train with other QA Associates. Responsible for Logbook issuance, control, and review. Files and maintains controlled documents. Other duties as assigned JOB REQUIREMENT Minimum 5 years of GMP-related experience in biopharmaceutical or pharmaceutical manufacturing. Bachelor's degree or diploma in Chemistry, Biology, Engineering, or a related field. Strong knowledge of cGMP/GDP requirements, international regulatory compliance, and GMP operations. 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. Apollo Health & Beauty Care Ltd. will ensure accommodations are available in consultation with candidates during all stages of the recruitment process. The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Duties outlined in this job description may not be all-inclusive, and can be modified at any time if requested by management. 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. Vacancy Status: This posting represents an existing vacancy, and we are actively recruiting to fill this position.

What you’ll do

The Quality Assurance Associate manages QMS responsibilities including deviations, CAPAs, change management, and SOPs to support commercial product release. They also perform internal audits and act as a Subject Matter Expert for investigations and quality risk management.

Requirements

Candidates must have a minimum of 5 years of GMP-related experience in pharmaceutical or biopharmaceutical manufacturing. A bachelor's degree or diploma in Chemistry, Biology, Engineering, or a related field is required.

Benefits

• Gym Access • Dental insurance • Health insurance

Listed skills

• Data analysis · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Quality Assurance
• GMP Compliance
• GDP
• CAPA Management
• Change Control
• Internal Auditing
• Deviation Management
• Quality Risk Management
• SOP Generation
• Batch Record Review
• Data Analysis
• Impact Analysis

Job areas

• Manufacturing
• Science & Research
• Healthcare
• Engineering