MFG QA Associate

Job Purpose

The purpose of the QA associate position is to ensure that all products processes and activities in the warehouse comply with industry regulations internal quality standards safety requirements and meet established standards of quality and compliance.

Duties and Responsibilities

The QA associate position is an individual contributor role and a member of the InvaGen Pharmaceuticals Plant Quality Team. The essential and typically expected job duties for this position include but are not limited to the following:


Verify that products and materials are stored at appropriate temperatures humidity levels and conditions in line with Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) regulations.

Ensure the pharmaceutical warehouse adheres to all applicable laws regulations and industry standards.

Handling of printed packaging materials dispensing of raw and packaging materials and handling of expired and rejected materials.

Ensure proper labeling and packaging of pharmaceutical products are consistent with regulatory guidelines and company standards.

Participate in internal and external audits prepare documents and assist in implementing corrective and preventive actions (CAPAs) for any identified issues.

Ensure that warehouse processes align with established Standard Operating Procedures (SOPs) and comply with safety and health regulations.

Review of logbooks and warehouse documents.

Quality oversight and checking of cleanliness in warehouse.

Ensure inventory levels and pharmaceutical products are tracked accurately through the use of inventory management systems (SAP).

Ensure that controlled substances temperature-sensitive items and other specialized pharmaceutical products are stored and handled correctly.

Conduct periodic checks of expiry dates batch numbers to ensure the proper rotation of stock (FIFO - First In First Out).

Provide training to warehouse personnel on quality standards regulatory compliance and safety procedures.

Support the development and continuous improvement of quality management systems within the warehouse.

Work closely with the warehouse management team to implement process improvements that enhance operational efficiency and product quality.

Investigate and resolve any non-conformities or quality-related issues identified during inspections or audits.

Coordinate with other departments (e.g. supply chain production or distribution) to resolve any issues promptly.

Initiate corrective actions and track them through to resolution.

Ensure the warehouse environment is compliant with health and safety standards.

Monitor the warehouse for proper sanitation contamination prevention and safe handling of pharmaceutical products.

Follow and enforce safety procedures to protect employees and the quality of the products.

Any activity allocated by department head.



Education


Advanced vocational training or education in pharmaceutical manufacturing industrial management or related field of study from an accredited college/university is preferred.

Minimum of two 2 years experience in quality assurance in a cGMP pharmaceutical manufacturing operation and work environment.

Experience in Warehouse QA is preferred.

Experience

Proficient user of personal computer hardware and software applications such as Microsoft Office tools SAP and other business applications.

Must be able to influence decision-making and facilitate completion of work toward the achievement of the business plan and goals.

Effective interpersonal relationship skills and the ability to work in a team environment.

Strong communication skills both written and verbal.

Must have current Good Manufacturing Practices (cGMP) knowledge.

Problem-solving skills and ability to implement corrective actions when necessary.

Professional and Behavioral Competencies


Must be willing to work in pharmaceutical manufacturing and packaging quality assurance.

Work schedule may be Monday to Friday.

Must be willing to work some weekends based on business needs as required by management.

No remote work available.



Physical requirements


Work standing or walking unassisted for 75 or greater of an 8-hour period. Unassisted lifting up-to 10 kg may be required.

Able to always wear appropriate personal protective equipment when required.

Sitting at a desk and/or working at a computer or other screen 75 or greater of an 8-hour period. Working conditions

SAP , INDUSTRIAL MANAGEMENT , QA , CGMP