USA-Quality Control Analyst II (Manufacturing/Quality) 1st Shift

USA-Quality Control Analyst II (Manufacturing/Quality) 1st Shift#25-64709

Swiftwater, PA

All On-site

Job Description

OVERVIEW:

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.

* Specific tasks may include:

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.

REQUIREMENTS:

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.

As a healthcare company and a vaccine manufacturer, *** has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated as required for your job responsibilities.

*** Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

EEO:

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.