Quality Assurance Associate

**POSITION SCOPE**:
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.

**RESPONSIBILITIES & DUTIES**:

- Completes APR reports in accordance to the schedule, gathering information available from batch records, investigations, product changes, complaints etc.
- Collaborate and liase 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.
- Incollaborationwith Quality colleagues identifies areas for continuous improvement within the QMS.
- Acts as Subject Matter Expert (SME) for 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 Quality Supervisor 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 SPECIFICATIONS**: **Knowledge/Education/Experience**:5+ years of GMP-related experience in biopharmaceutical or pharmaceutical manufacturing facilities. Bachelor’s degree or diploma in Chemistry, Biology, Engineering or related field; thorough knowledge of cGMP/GDP international regulatory compliance in addition to Regulatory/Operations experience in a GMP environment; ability to prioritize daily activities in order to meet internal and external customer needs in a fast-paced environment; ability to work on Quality projects where analysis of data requires evaluation of identifiable factors.
- **Interpersonal Skills/Contacts**:Regular access to confidential or sensitive information; frequent and regular internal interactions and frequent external interactions; purpose of internal/external contacts is regularly related to complex matters and may have high levels of consequence and costs associated with errors; occasional selling, negotiating, consulting, teaching/instructing, or advising; above average level of written and verbal communication skills required for successful job performance.
- **Problem Solving/Judgment**:Position has significant amount of autonomy in terms of level of monitoring and decisions generally do not follow prescribed guidelines; regular and frequent analysis required; regularly and frequently makes recommendations or referrals; responsible for frequently solving complex technical problems or personnel issues. **Mental Effort**:Requires high levels of concentration and/or attentiveness; sustained duration and/or intensity of efforts; requires high levels of thinking, watching, listening, verifying, checking numbers, creating or designing.
- **Physical Effort**:Occasional duration or intensity of physical effort; moderate energy required in terms of standing, walking, lifting, keyboarding, pushing, pulling, sitting, packing, assembling, bending or twisting; includes moderate fine or coarse movements.
- **Material Resources**:High level of consequence and costs associated with errors as related to losses of time, money, or property; high responsibility for significant machinery, work aids, equipment, materials, properties, products, stock, inventory or tools.
- **Information Resources**: High level of consequence and costs associated with quality errors as related to losses of time, money or property; moderate responsibility for information and or services; regular access to confidential, sensitive or proprietary information.
- **People/Policies/Practices**: Quality assurance responsibility for people, policies or practices in terms of assuring compliance in accordance to company policies. Regularly demonstrates work practices to others or is required to influence others to achieve output goals; overall re