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.

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.