Quality Control Analyst
*Job Description*
Job Summary:
The QC Analyst will support the establishment and growth of client’s QC department. Responsibilities will include, but not limited to, performing QC testing of DS/DP release and stability samples in support of Client programs ensuring compliance with established standards; cross-training with Analytical Development (AD) to enable assay transfer to QC and assay validation activities; and authoring and reviewing of method SOPs, protocols and reports.
Responsibilities:
- Execute Drug Substance and Drug Product release and stability testing in support of Phase I, II, III and commercial manufacturing of biotechnology products.
- Draft and execute Method Qualification/ Validation Protocols.
- Complete documentation needed to support testing procedures including data capture forms, equipment logbooks, or inventory forms.
- Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release.
- Write or revise Standard Operating Procedures, Work Instructions, Standard Test Methods and Forms.
- Generate Method Validation and Deviation/Out of Specification reports, Change Control requests and CAPAs.
- Monitor testing procedures to ensure that all tests are performed according to established item specifications, standard test methods, or protocols.
- Train other analysts to perform laboratory procedures and assays.
- Serve as a technical liaison between quality control and other departments, vendors, or contractors.
- Participate in functional teams with various experience levels and provide input as needed on assay issues.
- Supply quality control data necessary for regulatory submissions.
- Evaluate new technologies and methods to make recommendations regarding their use.
- Ensure that lab cleanliness and safety standards are maintained.
- Identify and troubleshoot equipment problems.
- Evaluate analytical methods and procedures to determine how they might be improved.
- Support QC laboratory inspection readiness strategy and activities.
Education & Experience:
- Bachelor’s degree and hands on-experience in Compendial assays testing (pH, A280, Sub-Visible Particles, Appearance), Endotoxin (Kinetic Chromogenic) and ELISAs.
- Experience with large molecules.
- Hands on experience in housekeeping of GMP QC Laboratories.
Required Knowledge, Skills & Abilities:
- Excellent verbal and written communication skills, including technical writing.
- Excellent organizational skills and attention to detail.
- Proficiency with Microsoft Office Suite.
- Strong level of initiative and quest for knowledge and growth.
- Ability to prioritize and manage tasks and operational flexibility.
- Ability to work well in a team and as an individual contributor.
- Ability to function well in a high-paced and at times stressful environment.
Job Type: Full-time
Pay: $12.58 - $22.77 per hour
Benefits:
- 401(k)
Schedule:
- 8 hour shift
Ability to commute/relocate:
- Frederick, MD 21701: Reliably commute or planning to relocate before starting work (Required)
Experience:
- large molecules: 1 year (Required)
- GMP QC Laboratories: 1 year (Required)
- pH, A280, Sub-Visible Particles, Appearance: 1 year (Required)
- Kinetic Chromogenic) and ELISAs: 1 year (Required)
Shift availability:
- Day Shift (Preferred)
- Night Shift (Preferred)
- Overnight Shift (Preferred)
Work Location: In person