Quality Assurance Associate/QA Manager

Indigene Pharmaceuticals, Inc., located in Westborough, Massachusetts, is looking for Quality Assurance Associate/QA Manager. Indigene, a rapidly growing biopharmaceutical company, was founded in 2002 with a strategic focus to develop and deliver innovative, safe, and effective healthcare products for the global CHC and Rx markets.

 

Description of the position:

 

Principal Accountabilities:Overall management of SOP system Develop and manage Indigene's GXP document management systems Serve as the quality representative on cross-functional and multi-site teams Develop and introduce plans to implement QA initiatives and continuous improvement



Duties and responsibilities:

v Overall management of SOP system: write, revise and update SOP's.

v Organize and conduct Quality Training Programs

v Develop and manage Indigene's GXP Document Management Systems

v Conduct Internal Audits

v Review contract manufacturing organization (CMO) documents, SOPs, and batch records

v Writing Quality Agreements with external contract manufacturers. Responsibilities may include the final release for all manufactured products

v Work directly with operating entities to ensure that inspections, statistical process control analyses and audits meet specifications

v Participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products

v Conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products

v Work with Research and Development during new product start-ups, and establish key checkpoints for new products and processes

v Interface with contract manufacturers to address documentation and compliance issues. Write and/or implement changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed. May interface with regulatory agencies as required

v Oversee Materials Management activities at Indigene and Indigene's Contract Operations



 

Qualifications and skills qualifications desired:

v Position requires a B.S. or equivalent with at least 1-2 years experience in the Biotech/Pharmaceutical industry and previous supervisory experience

v Good understanding of Quality Systems and regulatory expectations

v Excellent verbal and written communication skills, including the ability to influence others and lead complex projects

v Working knowledge of manufacturing processes, validation, and change control concepts for pharmaceutical manufacturing

v Strong attention to detail with strong documentation and coordination practices

v Demonstrated ability to multi-task and manage competing priorities

v Skilled at motivating and mentoring subordinates, working in a collaborative, team-oriented environment and accurately performing functions in a timely manner

 

This is an exciting time at Indigene. Our pace is fast and our team is energized. If this sounds like the place for you, and you share the same positive attitude _ we welcome your interest.