Quality Control Analyst I

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.

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.

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