Job Details

ID #51867753
Estado Pennsylvania
Ciudad Kingofprussia
Full-time
Salario USD TBD TBD
Fuente Lancaster Laboratories
Showed 2024-06-08
Fecha 2024-06-09
Fecha tope 2024-08-08
Categoría Etcétera
Crear un currículum vítae
Aplica ya

GMP Quality Analyst

Pennsylvania, Kingofprussia, 19406 Kingofprussia USA
Aplica ya

Company DescriptionEurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 47,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.Job Description

Water Systems

GMP review of microbiological testing of the facility and/or laboratory water purification system samples. Tests included are LAL and Bioburden.

GMP review of analytical testing of the facility and/or laboratory water purification system samples. Tests included are TOC, Conductivity, EU WFI Chemical Testing.

GMP review of Qualification and Media Release testing.

GMP review of facility cleaning data and in-processing testing, including but not limited to endotoxin, bioburden, BI, HPLC, ProtienConcentration, pH and Osmolality.

Initiation and follow-up of exceeded alert and action limits per procedures.

Participate in preparation of quarterly trending reports

Raw Materials

GMP review of general appearance/identifications and FTIR

GMP review of house gas/air sampling and testing

Initiation and follow-up of OOS and action limits per procedure

Electronic and physical receipt, log-in and distribution of samples and testings materials coming into QC.

Discarding / completing sample custody chain

Preparation and shipping of sample/materials

Aliquoting of bulk samples, assay standards, assay controls and customassay reagents

Laboratory Support

Assist in updating and writing SOP's

Routine calibration and maintenance of laboratory equipment which includes pipettes, balances, plate readers and pH meters

Cleaning of incubators, laminar flow hoods and biosafety cabinets

Cleaning of refrigerators and cold rooms

Defrosting of freezers

Disinfectant preparation

Maintenance of solvent wash bottles

Cleaning of water baths

GMP lab sweeps

Equipment out-of-tolerance (OOT) and refrigerator, freezer, incubator and pipette investigations

Weekly distributed control system (DCS) documentation review and maintenance

Participate as required in any investigations associated with their deliverables supporting this task order

Qualifications

B.S. degree with 1 yearof Quality Control experience in the Pharmaceutical industry

Experience in a Quality Control Lab is preferred

Work experience in a cGMP environment is required

Experience with Microsoft Word and Excel is req ired

Strong computer, scientific, and organizational skills

Excellent communication (oral and written) and attention to detail

Ability to work independently and as part of a team, self-motivated, adaptability, andapositive attitude

Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies

Authorization to work in the United States indefinitely without restriction or sponsorship

Additional InformationPosition is full-time, Monday - Friday 7am-3pm. Candidates currently living within a commutable distance of King Of Prussia, PA are encouraged to apply.

Excellent full time benefits including comprehensive medical coverage, dental, and vision options

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Eurofins Lancaster Laboratories Professional Scientific Services®(PSS) is a global, award-winning insourcing solution that places our people at our clients' site dedicated to running and managing laboratory services while eliminating headcount, co-employment and project-management worries.We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR and great place to work best practices, to recruit, hire, train and manage highly qualified scientists to perform laboratory services using our client's quality systems and equipment.To learn more about Eurofins Lancaster Laboratories, please explore our websitewww.eurofinsus.com.Eurofins is aM/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

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