Job Title: Quality Assurance Specialist
As a key member of our laboratory team, you will perform a wide range of analytical chemistry testing to support in-process and bulk drug substance manufacture in a compliant regulatory environment. This is a 24/7 shift position that requires the ability to work independently or as part of a team. You will be responsible for gathering data, documenting test results, reviewing results to ensure compliance with standards, reporting quality anomalies, and complying with all pertinent regulatory agency requirements.
Key Responsibilities:
* Gathering data and documenting test results
* Reviewing test results to ensure compliance with standards; reports any quality anomalies
* Complying with all pertinent regulatory agency requirements
* Participating in required training activities
* Maintaining laboratory supplies
* Conducting testing on raw materials, in-process, product, stability, and/or research samples
* Writing and revising control test procedures and SOPs
* Completing test records and reviewing data
* Calibrating or verifying calibration of instruments/devices prior to use
* Interacting with outside customers or functional peer groups
* Owning the responsibility for maintaining a specific project
* Devising or developing new analytical methods and techniques
* Assisting in validation of methods
* Participating in establishing the transfer of methodology from R&D
Required Skills and Qualifications:
* Proven ability to work independently or as part of a team
* Strong trouble-shooting and problem solving skills
* Strong attention to detail & excellent written and oral skills
* BS/BA in Life Sciences or related field
* 2+ years of relevant experience
Benefits:
* Comprehensive benefits package
* Health and wellness programs
* Equity awards
* Annual bonuses
* Paid time off for eligible employees at all levels
Equal Opportunity Employer: We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.