Quality Control Technician

3 days ago


Exton, United States Opusing LLC Full time

Title: QC Technician 1

Location: Exton, PA 19341

Duration: 12 months assignment

Shift: Confirm Schedule: M-F (7AM-3:30 PM)

Hourly pay range: $23-$25/hr. on W2


Job Description:

Top 3 Skills/Requirements: Chemistry/Biology Degree, No prior experience necessary

Potential for contract to hire? If so, salary range: N/A

Interview Process: Onsite or Teams


Purpose of the Job:

Reporting to the QC Manager, the Analytical QC Technician I support’s the accurate and timely testing and inspection of current products lines in their area of responsibility following customer requirements and/or established procedures. Analytical QC Technician I Analytical QC Technician I works with all areas of Operations and R&D in order ensure that products are of consistent and high quality by: conducting standard and non-routine laboratory tests, performing product inspections, and organizing data in a manner compliant GMPs.


Job Content:

a) Key Areas of Accountability / Responsibility:

Conduct laboratory tests and inspections on raw materials, in-process, and finished products.

Analyze and maintain all test data according to cGMPs.

Conduct thorough batch record reviews as part of material approval process.

Initiate NCRs as needed and execute the final disposition, including MRB transactions.

Organize laboratory supplies and documentation.

Authorized to release and transfer in-process and finished material in ERP system for sale, distribution, or further use.

Perform routine equipment maintenance and calibration on equipment.

Conduct routine environmental monitoring on controlled areas and water systems.

Offer suggestions on improvement of methods and implement through change control process.

Perform other duties as assigned.

Adhere to Biomedical Quality System procedures regarding ISO 9001and/or 13485 standards.


Lab Specific Duties :-

Microbiology (e.g. Endotoxin, Bioburden, Environmental Monitoring)

Wet Chemistry (e.g. Titrations, Moisture Testing, UV-VIS assays, Kjelhdahl Nitrogen, Hexanes, IV)

Spectral & Dry Chemistry (e.g. FTIR, XRD, PSD, Porosity, DSC, Ash Content, Solids)

Analytical Chemistry / Chromatography (e.g. GC, SEC, HPLC)

Bioanalytical (e.g. DNA Quantification, Micro-BCA, Blyscan)

Mechanical Testing (e.g. Suture pulls, Wet Tear, Compression, Injection)


Knowledge and Educational Level:

Associates degree in the biological or chemical sciences. Years of experience may be substituted for degree.


Required Level of Experience:

Minimum 0-3 years of experience demonstrating progressive inspection and testing responsibilities in a laboratory setting

Inspection and testing experience within a GMP or ISO 9001 and ISO 13485 environment

Knowledge of commonly used concepts, practices, and procedures within a QC environment

Basic knowledge & understanding of sampling techniques (ANSI/ASQC Z1.4-2003)

Must have excellent writing, editing and proofing skills

Proficient using MS Word, Excel and Outlook



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