Job Description

JOB DUTIES and DESCRIPTION:

The QA Assistant serves as the department's primary administrative support. As part of the company's quality assurance cGMP compliance strategy, the QA Assistant co-operates with QA Manager to manage official records from pre-production issuance to archival retention.

Essential responsibilities include, but not limited to:

Performs direct oversight of manufacturing activities to ensure cGMP compliance.

Performs post processing batch record reviews/correction assistance.

Performs post processing yield verification.

Conducts routine and scheduled inspection of plant areas, equipment and personnel to ensure cGMP compliance. If discrepancies in cGMP, procedures, systems and techniques are observed, the QA Assistant assists QA Manager initiates appropriate corrective action, documents the issue/event and if necessary, immediately stops production until the issue is corrected.

Monitors work in process for proper use of materials, correct recordings and possible sources of cross-contamination and reports all deviations to QA Manager.

Adheres to all cGMPs, compliance/regulatory mandates and quality requirements.

Works with Production Department, QC department and QA Manager to draft or revise the required SOPs.

Performs other related duties as assigned to meet departmental and Company objectives.

Ensuring the integrity and security of all retained documents, logs, and operating procedure by performing quality assurance functions to accomplish company-wide coordination, monitoring, and reporting of quality related events and relevant documentation.

Comprehensively reviewing and approving all documents for accuracy.

Assists department with the coordination of audit information and recommends appropriate data-gathering mechanisms, procedures, etc.

Organizing (and re-designing as needed) the department's document-retention system.

Monitoring document version control & managing official document copies.

Conducting Trainings when QA manager is not available.

Researching compliance & departmental questions.

Attending meetings, taking minutes, and disseminating information through team members as well as other departments as it relates to them.

Continually recognizing and initiating improvements to QA documentation and retention practices.

Resolving any documentation inconsistencies by investigating the source(s) of such oversights.

Assisting the QA Manager and all other QA personnel with new or revised documentation.

Informing QA and production personnel of any new or updated QA procedures.

Handling document creation, collation, and status (in-process, rejected, active, inactive, archived, etc.)

Review and sign production documents, QC releasing documents, CoAs, and other documents on behalf of QA Manager once the Manager is not available.

Co-operate with QA manager, prepare and handle third party inspection.

Other responsibilities as assigned by Top management related to Quality Assurance.

Qualifications:

Bachelor's degree in Chemistry, Biology, or a related scientific field Excellent communication, coordination, and problem-solving skills Proficient in office software and data reporting
Job Types: Full-time, Permanent

Pay: From $21.00 per hour

Expected hours: 40 per week

Benefits:

Dental care Extended health care Vision care
Education:

Bachelor's Degree (required)
Experience:

natural health products industry: 1 year (preferred)
Work Location: In person