Quality Control Analyst II

Quality Control Analyst II

SGS_JOB_1857

Scientific

Pennsylvania

cGMP

Chemistry

Pharma

TOC

Conductivity Analysis

Raw Material Testing (pharmacopeia/wet chemistry assays)

pH Testing

Buffer Assays

Sample Preparation

QC

Contract - 12 Months (possible extension)

This position supports the execution of routine testing in the Quality Control Analytical Chemistry laboratory, including chemistry assays associated with Incoming Quality and Raw Materials. This position requires proficiency and understanding of the theory related to processes, assays, and equipment, as well as the ability to identify issues/trends. The candidate filling this position will work to ensure tasks are completed in a timely manner, while strictly adhering to policies and procedures and cGMP.

Job Responsibilities:

Perform QC testing while strictly adhering to policies and safety procedures, SOP/SWI, Pharmacopeia, Federal Regulations, cGMP, and required training curricula.

Perform all scheduled activities defined by laboratory management to meet demands of Production, Method Development, Validation, Independent Demand, and Stability program.

Maintain safety and compliance of the laboratory work area.

Perform cleaning of laboratories, equipment, and ancillary areas as required.

Prepare for and operate QC equipment including pre and post-run setup and maintenance.

Complete required paperwork and documentation as required.

Troubleshoot sample discrepancies.

Perform peer proofing on assays.

Develop a working knowledge of appropriate compendia and/or regulatory guidance.

Attend/contribute to scheduled team meetings, department, and safety meetings.

Skills:

Raw material testing (pharmacopeia/wet chemistry assays) Water testing (TOC and Conductivity analysis)

pH testing for media

Buffer assays (titrations and photometric methods)

Analytical equipment setup, usage, and maintenance

Sample preparation and disposal

Coordination of contract laboratory testing

Chemical handling required with appropriate PPE provided. Vaccinations and vision examinations may be required based on specific job function.

Education/Experience:

Bachelor's degree in Chemistry or equivalent

2-4 years of relevant experience in cGMP controlled/pharmaceutical industry.

Exceptional attention to detail and strong writing skills are crucial.

The candidate must be able to work in a dynamic team environment with flexible schedule, including potential for weekends/holidays.

Prefer local, open to candidates willing to relocate at their own expense

Onsite Education: BA Chemistry

Must-Have Experience with: entry level with experience in Chemistry and Pharma

Work Experience: 4 years (academia & industry)