Careers

QA Associate - Part-time

Lindy Biosciences is solving critical formulation challenges in the biotherapeutics market through our Microglassification technology. Our platform produces high-dose suspensions of therapeutic proteins suitable for subcutaneous injection — a formulation approach that reduces administration costs, improves patient comfort and compliance, and enables a new class of high-dose molecules to reach patients.

We have a dedicated team of unique thinkers and problem-solvers. As a small company, every employee has a tremendous impact on our success, and we have abundant opportunity to learn, innovate, and challenge each other. We are passionate about improving our knowledge, skills, products, and ultimately improving the drug delivery experience for patients. 

The Alliance Project Manager should be passionate about organizing ideas, logistics, technical details, and driving collaborative product development. This role is the bridge between biopharmaceutical client needs and scientific execution, overseeing complex pharmaceutical projects for partner programs from development to commercial manufacturing. This role involves oversight of process improvements, regulatory compliance, and technical leadership in development and manufacturing. The Alliance Project Manager will work closely with senior leadership and department leads, acting as a point of integration across the team. Externally, the Alliance Project Manager will collaborate closely with our biopharmaceutical clients and manufacturing partner.

The part-time QA Associate will be responsible (with some supervision) for reviewing data and batch records and helping maintain all company Standard Operating Procedures (SOPs), work instructions, and quality records.  You will oversee the routing of controlled documents through their lifecycle – including creation, review, approval, distribution, revision, and secure archiving. 

Position Overview:

• Part-time, hourly position, approximately 20 hours per week.

• Hybrid position – some work needs to be done at Lindy Biosciences’ headquarters; other projects can be done at home.

Key Responsibilities:

• Manage the routing, tracking, review, and approval of controlled documents.

• Facilitate high-level cross-functional QA review of controlled documents.

• Work independently.  Tasks will be explained and set up ahead of time and will be executed with minimal supervision.

• Track and archive completed quality records, training logs, and batch documentation.

• Track metrics related to document reviews, cycle times, and overdue document revisions.

Competencies/Essential Skills:

• Quality: ALCOA+ documentation and experience with controlled batch records.

• Attention to Detail: Ability to perform tasks consistently and correctly

• Computer and Technical Skills: Embrace and adapt to technology required to fulfill responsibilities of this position, including but not limited to: Microsoft Word, Excel, Outlook, PowerPoint, Teams, and Project Management software (e.g., Smartsheet).

Minimum Required Education and/or Experience 

●      Associate’s or Bachelor’s degree in Quality Management or a relevant scientific field.

●      1-3+ years of experience working in QA, document control, or records management within pharmaceutical, biotechnology, or associated field.

●      Knowledge of GxP highly recommended.

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Supervisory Responsibilities

None

Travel

None

Affirmative Action/EEO statement: 

Lindy Biosciences is an equal employment opportunity employer and does not discriminate against any person because of race, color, creed, religion, national origin, political affiliation, sex, gender identity or expression, sexual orientation, age, disability, genetic information, or other reasons prohibited by law (referred to as "protected status"). This nondiscrimination and opportunity policy extends to all employment actions such as promotions, compensation, benefits and termination of employment.

Other duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.