Employment Type: Permanent Position

Job Category: Quality Assurance

Department: Quality Assurance

Reports To (Position): Director, Quality Assurance

Job Number: 3327825

Position Overview:

Reporting to the Director, Quality Assurance, this position will assist in ensuring GxP compliance and quality oversight for manufacturing operations. This role will collaborate across the company and support the filing of multiple investigational new drug applications and be part of the transformative shift the company is making as we move from the pre-clinical stage to IND enabling studies and to accelerated clinical development. The selected individual will be a team player in a small company environment in this highly cross-functional role.

Accountabilities and Responsibilities:

• Review and approval of Quality System and cGMP documents including, but not limited to, SOPs, Batch records, protocols and specifications.
• Review and approval of change controls, non-conformances, OOS, deviations, complaints and related items; ensure investigations are thoroughly investigated and resolved.
• QA review of manufacturing and QC related records, resolution of all related issues and QA disposition of product batches.
• Provide on the floor support during ongoing product manufacturing and testing.
• QA review and disposition of raw materials, buffers, labels, and other components.
• QA review of initial qualification, validations and re-validations for facilities, equipment and processes.
• QA oversight and review of QC qualifications and validations.
• Responsible for generation, inspection and release of labels.
• Provide support and QA oversight of drug product shipments to clinical sites.
• Responsible for maintaining the company’s controlled documents in accordance with GxP requirements.
• Ensures escalation of quality issues to management as appropriate.
• Assists in identifying and implementing process improvement opportunities to existing systems.
• Work closely with cross functional teams to ensure all work is completed to high quality in a timely and scientifically rigorous manner.
• Other duties as required.

Essential Details:

Work Schedule

Full-time; days. The role will mostly involve standard working hours, but flexibility is required to attend meetings/calls and QA support of production activities.

Travel

The role may include travel to meet vendors and attend conferences and meetings.

Safety

The role requires adherence to all company safety policies and procedures.

Quality Responsibility

Development and maintenance of quality systems and GxP compliance for the business by ensuring that team members comply with processes, procedures and instructions for all activities in which the team participates.

Scope

Works on complex problems where analysis of multiple factors and consideration of data must be interpreted for decisions to be made. Must be able to utilize past experience and established industry practices to temper decisions under consideration. Exercises judgment within a broad spectrum of situations which affect product, policy and procedures. This is a supportive role within the company and will provide responsibility for Quality Assurance. The role will involve working closely with the Quality Assurance team as well as operational teams across the company.

Leadership Responsibility

The role is to provide support in development and maintenance of quality systems and GxP compliance. The role will involve working closely with the Quality Assurance team, as well as operational teams across the company.

Work Environment

A majority of the work is done in office, cleanroom and lab environments, with use of a laptop, or in meetings held in a conference room. Eyestrain and/or repetitive motion symptoms may occur due to extensive use of the computer.

Minimum Requirements:

Education

Bachelor’s degree in life sciences (Chemistry, Biology, Microbiology, Biochemistry), pharmacy or related engineering field

Experience

At least 3-5 years of relevant experience in the biotech/pharmaceutical industry

Licenses or Certifications

GMP and/or Quality certifications a plus

Knowledge

• Working knowledge of cGMP requirements for biologics manufacturing. Working knowledge of requirements for aseptic manufacturing. Basic knowledge of cell biology, cell culture.

Skills

• Ability to work collaboratively in matrix organizations and team.
• Ability to interpret cGMP requirements.
• Must have strong organizational skills and be able to manage and prioritize multiple projects or assignments at one time, including the ability to follow assignments through to completion and meet deadlines.
• Excellent communication (verbal and written) skills required.
• Problem solving skills and ability to make quality decisions based on technical facts and sound risk assessments is required.
• Continuous strong focus on meeting or exceeding expectations in executing deliverables, performance and results.
• Ability to track and measure performance against defined metrics.
• Self-starter with high degree of energy, independence, initiative, and self-motivation, as illustrated by the ability to instill a sense of pace and urgency into the team.
• Someone who moves fast and decisively in a balanced manner, with a passion for the growing company.
• Passionate, collaborative, creative, willing to take prudent risks, and motivated by the creation of a company focused on transformative treatments for patients and their families.