Quality Control Analyst I

Job Details

Description

The QC Analyst I is responsible for performing incoming raw materials, in-process samples, intermediate products, and final products analytical analysis per approved internal and customer specifications following associated procedures to support both product manufacturing and commercial product release. Will work under the supervision of more experienced analysts and follow established procedures and protocols. This position is a full time onsite at our Warrington, Pa facility. 

Essential Functions: 

Performs routine analytical analysis using the following equipment: volumetric glassware, balances, pH Meter, Conductometer, Karl Fisher (KF), TOC, Turbidimeter, GC (FID/MS), Atomic Absorption (AA), and others as required.

Responsible for QC data analysis and data entry, using both electronic systems and hard copy documentation following GDP

Ability to effectively communicate with cross-functional teams, including production, quality assurance, and planning.

Reports OOS results to QC Manager or designee and assists with compiling required information to complete the investigation report.

Performs daily and monthly analytical equipment verification and maintenance. 

Flexibility to handle unexpected situations and make adjustments to ensure compliance with 820 GMP and ISO 13485 standards.

Assists on the review and revision of procedures and test methods.

Assists on laboratory inventory maintenance.

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

Supports process improvements within the QC laboratory.

Qualification:

Knowledge and experience in routine analytical analysis and maintenance with a combination of the following equipment: volumetric glassware, balances, pH Meter, Conductometer, UV-Vis, FT-IR, Karl Fisher (KF), TOC (Total Organic Carbon), Turbidimeter, GC-Gas Chromatography (FID or MS), and/or Atomic Absorption (AA), is required

Performs daily and monthly analytical equipment verification and maintenance as required.

Experience analyzing analytical data, maintaining quality control records, and performing data entry, using both electronic systems and hard copy documentation following GDP (Good Documentation Practices) is required.

Experience with at least one of the following analytical equipment software: Open Lab, Chem Station and Empower required.

Proficiency with Adobe, Microsoft Word and Excel required

Ability to effectively communicate with cross-functional teams.

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

Must support process improvements within the QC laboratory.

Bachelor’s degree in chemistry or related science field required.

At least one (1) year of experience working in an ISO 13485 or FDA GMP regulated environment 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.

Poly 424

Qualifications

Qualifications

Education Required: Bachelor's Degree Preferred: Bachelor's Degree

Certification(s):Specify preferred or required.

Computer Skills Required: Specify preferred or required.

Experience with Open Lab, Chem Station and/or Empower analytical software preferred.

Proficiency with Adobe, Microsoft Word and Excel required.

Other qualifications:

Bachelor’s degree in chemistry or related science field required.

At least one (1) year of experience working in an ISO 13485 or FDA GMP regulated environment preferred.

Bachelor’s degree in chemistry or related science field required. At least one (1) year of experience working in an ISO 13485 or FDA GMP regulated environment preferred.

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

Knowledge of analytical equipment, analytical methods, and data analysis required.

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

Immediate Work Environment:

X-Chemicals Unprotected Height X-Fumes/Gases Persistent Noise

X-PPE used: Lab Coat, Safety Shoes, and Safety Glasses

Work Activity: [must equal number of hours worked per day]

Stand: 4 Frequency: Intermittently Walk: 1 Frequency: Intermittently

Sit: 3 Frequency: Intermittently Drive: 0 Frequency: Choose an item.

Lift/Carry Demands

Frequency: Lift/Carry Equipment Provided:

0-10 lbs. 1-3 hours a day Reagents Bottles Carriers

11-25 lbs. Not Daily Rolling Cart

26-50 lbs. Rarely Gas Tank Hand Cart/Drum Lift Cart

51-75 lbs. Never Click or tap here to enter text.

76-100 lbs. Never Click or tap here to enter text.