Quality Control Analyst I

Polysciences; Warrington Township (Bucks County); On-site; USD 59,000 - 70,000; Full time

Benefits offered by this job

Comprehensive Benefits

401(k) with company match

Job summary

Polysciences is seeking an Entry-Level QC Analyst I in Warrington, PA 18976 to perform analytical testing on raw materials, in-process samples, intermediates, and final products to support manufacturing and product release.

Under supervision of more experienced analysts, you will use multiple instruments, document results per GMP/ISO 13485, and contribute to QC improvements. A 4-year degree in chemistry or related field is required, with 1 year in a regulated environment preferred.

Qualifications

• Bachelor's degree in chemistry or related science field required.
• At least one year of experience in 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 (USP, EP, ISO, ASTM) preferred.
• Experience with OpenLab, Chem Station and/or Empower analytical software preferred.
• Proficiency with Adobe, Microsoft Word and Excel required.

Responsibilities

• Performs routine analytical analysis using various equipment (KF, GC, AA, pH meter, Turbidimeter, etc.)
• QC data analysis and data entry following GDP
• Communicate with cross-functional teams (production, QA, planning)
• Report OOS results and assist investigations
• Daily/monthly instrument verification and maintenance
• Assist revision of procedures and test methods
• Maintain lab inventory and a clean, safe 5S environment
• Support process improvements within QC laboratory

Job description

Job DetailsLevel: EntryJob Location: Warrington, PA 18976Position Type: Full TimeEducation Level: 4 Year DegreeSalary Range: $59,200.00 - $69,800.00 SalaryTravel Percentage: NoneJob Shift: M-F / 1st shiftJob Category: QA - Quality ControlPolysciences 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 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.

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.

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.
• 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.
• Experience with Open Lab, Chem Station and/or Empower analytical software preferred.
• Proficiency with Adobe, Microsoft Word and Excel required.

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
• 3 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 & Rewards
• Basic & Supplemental Life Insurance
• Accident, Hospital Indemnity, & Critical Illness
• Paid Time Off
• Paid Parental Leave
• 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.

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: 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

76-100 lbs. Never

QualificationsQualifications

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.