What are the responsibilities and job description for the QA Technical Services Specialist position at Lead Candidate?
QA Technical Services Specialist
WHO?
The Quality Assurance Technical Services (QATS) Specialist is responsible for reviewing and approving Quality Control (QC) and Incoming Quality Control (IQC) documentation. This documentation includes data from QC Microbiology, Chemistry, IQC and Method Transfer. The QATS Technical Services Specialist will work in coordination with Quality Control Technical Services (QCTS) to perform periodic walkthroughs of the Quality Control laboratories to ensure good laboratory practices are followed and the areas meet regulatory inspection readiness.
WHAT?
- Perform laboratory data review processes for incoming materials, in-process, finished product, and stability testing from QC Chemistry, Microbiology, IQC and Method Transfer.
- Partner with Quality Control in the data analysis and data review process.
- In coordination with QA and QC management, use knowledge of quality principles, cGMPs, and regulatory standards to maintain a state of constant inspection-readiness in the QC laboratories.
- Utilize various paper and automated systems (Veeva, SCADA, BMS, CMMS, etc.) to ensure data integrity for all Quality Assurance and Quality Control site policies, procedures, and testing records.
YOU!
- This position will support primarily second shift (3:00-11:30pm) with occasional weekend support, dependent on operation’s needs.
- Bachelor’s Degree required in Science (Chemistry, Biology, Microbiology or Biochemistry) or 5 years relevant experience.
- Minimum of 4 years’ experience of GMP biopharma industry experience, with at least 1 year experience with isolator-based aseptic manufacturing environments required.
- Experience as a technical data reviewer in a GMP regulated industry.
Why INCOG?
- Paid time off, based on tenure
- 11 paid holidays
- 401(k) plan with company match up, vested immediately
- Choice of health & wellness plans
- FSA and HSA options
- Onsite wellness facility
- Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations
Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…
Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.