A brief overview
The Quality Control Scientist performs laboratory day-today operations, guides and interacts with QC and department personnel to accomplish goals and objectives as directed by supervisor. Other duties include performing raw material testing, final product testing, QC documentation and related GMP activities.
Shift : Monday - Friday 7:00am - 3:30pm
What you will do
- Maintain and perform daily operations in coordination with the QC Director/Supervisor to include testing of raw material/peptide samples and prioritizing projects
- Write and work with other QC Staff and other Department in the creation and approval of control documents such as specifications, SOPs, STMs, etc.
- Maintain and perform regular verification of the QC equipment for GMP compliance regularly in coordination with QC Director / Supervisor
- Implement and maintain GMP procedures such as following SOP’s, Standard Testing Procedures (STP’s), written procedure and maintaining proper documentation as necessary for Quality Control
- Test, review, and release raw material used in the manufacturing facility for GMP. Performing analytical analysis and reviewing data for completeness and accuracy
- Receive, test and release final product peptide manufactured at Bachem
- Test and release in-process control samples used in the manufacturing facility for GMP. Performing analytical analysis and reviewing data for completeness and accuracy
- Maintain a cGMP quality level of work for the QC operations to include training, documentation and procedural work
- Write/revise specifications as necessary, performing analytical analysis and reviewing data for completeness and accuracy
- Write standard operating procedures, standard test procedures and other related GMP documentation
- Implement and maintain GMP procedures such as following written procedure and maintaining proper documentation as necessary for Quality Control
- Perform QC analysis to include: HPLC, UPLC, Water, Mass Spec, UV, GC, melting point, Optical Rotation, TLC and misc. wet chemistry lab work and other related analytical equipment used for control quality of the GMP facility. This work may include calibration and validation of these methods
- Control raw material used in the manufacturing facility for GMP to include receiving, quarantine, testing and QC release
- Investigate any deviation or out of specification as necessary related to QC work performed as instructed by supervisor
- Execute validations as necessary to include QC Analytical methods performed, other validations to support the quality of the manufacturing facility
- Follow safety guidelines for handling, disposal and use for a peptide manufacturing company using toxic and/or large volumes of chemicals
- Support validation, and stability as necessary to include but not limited to analytical work, documentation and quality GMP procedure
Qualifications
- Bachelor’s degree in chemistry or related field
- Master’s degree in chemistry or related field (preferred)
- Minimum of 3 years' experience in GMP pharma/biotech facility
- Experience with Equipment Maintenance Programs
- Experience with the use of analytical techniques / instruments, including GC, HPLC/UPLC, & UV-Spectrophotometer
- Excellent written and oral communication skills
- Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
- Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
- Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
- Detail oriented with the ability to troubleshoot and resolve problems
- Ability to work independently and manage one’s time
- Communicate effectively and ability to function well in a team environment
- Ability to review Certificate of Analysis for Reagents for the creation of specification documents
- Organization skills to support the department in the creation and approval of controlled documents in a timely manner
- Flexibility of working hours based on business needs, may include some nights and occasional weekends
