Quality Control Analyst II at Polysciences, Inc. in Warrington, Pennsylvania

Job Description:

Who We Are

Ott Scientific

The Ott Scientific family of companies comprises Polysciences, Bangs Laboratories, and Ethos Biosciences. Together, we bring the whole of our experience with best-in-class facilities and scientific, technical, analytical, and manufacturing capabilities to serve customers around the globe. We deliver highly specialized products and services that support scientific discovery and innovations.

Polysciences

Polysciences technical operations and scientific laboratories offer custom synthesis, contract manufacturing and packaging, and laboratory products. We are proud to offer a broad range of products and tailored solutions for the life sciences, bioprocessing, microparticles, medical device, specialty chemical and eChem industries. We adhere to ISO13485:2016, FDA cGMP 21 CFR 820 regulations, and SOCMA’s ChemStewards® Management System. We believe the best scientific innovations are built through collaborations.

The QC Analyst II is responsible of performing incoming raw materials, in-process samples, intermediate products, final products, and stability samples analytical analysis per approved internal and customer specifications following associated procedures to support both product manufacturing and commercial product release. QC Analyst II is also responsible to support the QC Laboratory systems such as equipment maintenance, OOS investigations, inventory, Logbooks, etc. This position involves advanced testing responsibilities and requires strong people skills for effective collaboration within the regulated framework

Essential Functions: Fundamental and critical tasks, duties, and responsibilities necessary for position to be performed effectively.

• Capable of performing all the QC Analyst I essential functions.


• Performs routine analytical analysis using the following equipment: volumetric glassware, balances, GC-MS, GC-FID, LC-DAD, LC-MS, NMR, TGA, DSC and others as required.


• Responsible for peer review of QC data, using both electronic systems and hard copy documentation following GDP.


• Works collaboratively with cross-functional teams to ensure seamless communication and coordination effectively communicating complex test results and quality-related issues to team members, other departments, and stakeholders.


• Reports OOS results to QC Manager or designee and compiles required information to complete the draft investigation report with management assistance.


• Performs daily and monthly analytical equipment verification and routine upkeep as well as assist in equipment and software troubleshooting. 


• Manages laboratory inventory and it is responsible to escalate any necessary purchase request to QC Manager or designee in a timely manner to not impact TAT.


• Executes the review and revision of procedures and test methods with management assistance.


• Interface with internal and external partners to address inquiries, coordinate QC related activities and provide information related to quality control processes.


• Provides guidance and training to QC Analysts I and other team members.


• Responsible for sampling incoming raw materials and coordinating 3rd party laboratory testing when required.


• Maintains a safe, clean, and organized environment (5S) for all QC areas.


• Supports process improvements within the QC laboratory.

Education Required: Bachelor's Degree, Chemistry or related field                          

Certification(s): Six Sigma or related certification preferred.

Computer Skills Required: Experience with Open Lab, Chem Station and/or Empower analytical software required.

Proficiency with Adobe, Microsoft Word and, Excel.

Other qualifications:

• Bachelor’s degree in Chemistry or related science field required.


• At least three (3) years of experience working in an ISO 13485 or FDA GMP regulated environment required.


• Experience with quality control GMP documentation of testing results and assurance of laboratory data integrity and compliance required.


• Knowledge of analytical equipment, analytical methods, and data analysis required. Wet Chemistry, GC-FID, GC-MS, LC-DAD, LC-MS, LC-RI, Light Scaterring Detection, Karl Fisher (KF).


• Knowledge of compendial methods (ie. USP, EP, ISO, ASTM) preferred.

What We Offer

Culture

Great people

Peer to Peer Recognition

Broader, hands-on work experience

Clean and Modern Equipment & Labs

Fun company events

Competitive Wages & Generous Year-end Bonus

Comprehensive Benefits

4 Medical PPO Medical Plans with Telemedicine, Rx, & Vision

2 Dental Plans

Healthcare, Dependent care, & Commuter Flexible Spending Accounts

401(k) with company match

Financial Health & Wellness w/1:1 Coaching

Basic & Supplemental Life Insurance

Accident, Hospital Indemnity, & Critical Illness

Paid Time Off

Short & Long-term Disability

9 Paid Holidays

Must have legal authorization to work in the US and will not require sponsorship.

Polysciences is an equal opportunity employer. Drug-free workplace. Tobacco-free work site.

Polysciences does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other basis covered by appropriate law.  All employment is decided on the basis of qualifications, merit and business need.

Equal access to programs, services, and employment is available to all persons.  Those applicants requiring reasonable accommodation to the application process and/or interview process should notify a representative of the Human Resources Department.

Find us here Poly 424

Apply Now