Quality Control Associate

  • Full-time

Company Description

Rejuvenate Bio is using a convergent, multi-disciplinary approach, combining gene therapy, proprietary targets, and the animal health market to bring human age-related therapies to market. We are targeting the core drivers of chronic age-related diseases by unlocking the power of gene expression and epigenetic reprogramming to reverse pre-existing heart disease, metabolic disease, and kidney failure in humans.

Each therapy we’re developing has the potential for therapeutic impact across multiple disease indications, with each new piece of data validating the approach and increasing the value of each clinical program. This will allow us to rapidly expand each product into multiple indications. Additionally, our animal health programs provide an untapped market for early revenue and further validation for use in humans.

Job Description

We are seeking a detail-oriented Quality Control Associate to join our growing Quality team! This position is ideal for entry-mid level candidates who thrive in a fast-paced work environment. The QC Associate will be responsible for screening and analyzing cell lines through cell-based assays, and testing in-process and lot release samples (ex. mycoplasma, bioburden, sterility, genomic ID, capsid ID, titer etc...). While this role is primarily lab-based, responsibilities also include initiating quality events such as Out of Specifications, assisting in PQs of newly developed SOPs, and performing QC data review of reports for accuracy, specification approval, and compliance. This role reports to the Sr. Director of Quality & CMC.   

Responsibilities:

  • Review and approval of ancillary documentation associated with laboratory testing including logbooks, forms, raw data, etc. 
  • Adhering to Good Manufacturing Practices and GxP guidelines when performing QC testing. 
  • Screening and analyzed cell lines through cell-based assay test such as ELISA 
  • Works with QA to close out quality events related to release testing or protocol development at external labs. 
  • Assist with the review of laboratory records and associated documentation required for lot release. 
  • Execute qualification protocol method of various assays. 
  • Work with Contract Testing Labs (CTL) and Contract Manufacturing Organizations (CMO) to coordinate shipping and testing of samples for lot release, investigations, PPQ, PSQ and will compile vendor documentation to generate a CoA/CoT. 
  • Responsible for the accurate, timely and compliant execution of assigned projects, related documentation, and any other tasks as assigned by management. 

Qualifications

  • Bachelor's degree in Biology, Chemistry, or relevant Life Sciences field. 
  • Some experience performing mammalian cell culture (splitting cells, transfection, etc) during or after undergrad. 
  • Strong work ethic, communication skills and goal-oriented personality. 
  • Prior experience performing ELISA or PCR-based assays.
  • Experience performing QC testing while adhering to Good Manufacturing Practices and GxP guidelines. 
  • Prior experience in the gene therapy field is highly preferred. 
  • Working knowledge of industry guideline including GxP, cGMPS, ICH, CFR, and global regulations as appropriate. 
  • Experience with Quality Systems (change control, deviation, and investigation) is a plus. 

Additional Information

Base Salary: $65k - $70k; exact salary and job title will depend on experience.

Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Position is primarily sedentary, and employee may be required to sit for extended periods of time.
  • Standing, walking and meeting activities are required frequently throughout the workday.
  • Must be able to process paperwork and utilize office equipment (including personal computer, phone, copiers, etc.).
  • Normal sight or corrected vision is required to read documents and use standard computer terminals. Some light lifting may be occasionally required.
  • Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards.
  • Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state and local standards
  • Must be able to lift and carry up to 25 lbs
  • Must be able to talk, listen and speak clearly on telephone

EEO Statement
Rejuvenate Bio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Rejuvenate Bio is an E-Verify Employer in the United States. All your information will be kept confidential according to EEO guidelines.

The health and safety of our employees and their families is a top priority. The company encourages employees to remain up-to-date on their COVID-19 vaccinations. Rejuvenate Bio, Inc. employees may be required, in the future, to be vaccinated or have an approved disability/medical or religious accommodation.

Privacy PolicyImprint