Job description

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

Salary: $51,517.82 - $80,032.38 per year

Benefits:

• 401(k)
• Dental insurance
• Flexible spending account
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Frederick, MD 21701: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Manufacturing: 1 year (Preferred)

Work Location: One location

Speak with the employer
+91 +13023215612

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