Quality Assurance Specialist
Company Overview & Position Description
- EpiBone is a clinical-stage company that develops revolutionary tissue engineered products for skeletal repair and is offering the opportunity to join an early-stage company to support the clinical translation of innovative regenerative stem cell therapies. The candidate will be working with a passionate and diverse team at EpiBone on a mission to commercialize cutting edge medical products that truly restore body function.
- The company is seeking a QA Specialist to join our QA team to support good laboratory practice, cGMP manufacturing and quality control testing, including documentation related to batch production. Create, revise and manage controlled documents, using Electronic Document Manage System as the company transitions toward large-scale clinical trial.
Essential Functions & Responsibilities
- Support all Quality Management objectives.
- Writes/revise SOPs, protocols, validation plans and compliance documents for cGMP program as directed.
- Assist in set-up of cGMP program for manufacture and QC testing activities.
- Support departmental resource for cGMP programs on a day-to-day basis.
- Ensure qualification of instruments, equipment, facility, clean rooms and computer hardware – software.
- Sets-up and organizes tracking program for equipment used for cGMP purposes.
- Reviews of batch production records and quality control documentation.
- Performs internal audits as required and ensures observations are corrected.
- Set-up and track material flow and material-labeling process to ensure compliance with cGMP program.
- Assist in training staff in area of cGMP/GLP and maintains training records.
Minimum Qualifications
- BS/BA in science with 1-3 years Quality Control/Assurance cGMP experience in any area of Pharmaceutical or medical device manufacturing or related industrial experience.
- 0-2 years of experience in biopharmaceutical based GMP manufacturing operations.
- Familiarity with Microsoft applications.
Preferred Qualifications
- 2-4 years of Quality Control/Assurance cGMP experience in any area of Pharmaceutical or medical device manufacturing.
- Proficient in technical writing (SOPs/protocols and reports).
Working Conditions/Physical Demands
- Visa sponsorship is not available for this position.
- No relocation assistance is provided for this position.
- Ability to lift 25lbs or more on a regular basis.
Employment Status
- Full-time
- Exempt from overtime.
**Qualified applicants, please submit your cover letter and resume for consideration to: carla@epibone.com**
- EpiBone, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, gender, gender identity or expression, religion, sex, sexual orientation, national origin, age, disability, or genetics. In addition to federal law requirements, EpiBone ,Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.