QA and QC Specialist

Eurofins; Sanford (NC); In loco; USD 80.000 - 110.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, dental, and vision benefits

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Descrizione del lavoro

Eurofins USA PSS Insourcing Solutions in Sanford, NC seeks a QA professional to oversee QC activities in a biotech/pharma setting. GMP experience is required, with hands-on oversight over method validation, equipment qualification, and change controls.

You will support investigations into QC deviations, drive process improvements, and ensure compliance with regulatory requirements. A BS/BA with 4+ years in biotech/pharma quality is expected.

Competenze

• Requires BS/BA in a related field and minimum 4 years of experience in manufacturing, laboratory, quality, technical or engineering within biotech/pharmaceutical industry.
• GMP experience is required for this QA oversight role.
• Direct experience with method transfer validation, investigations, change controls, and equipment qualification is needed.

Mansioni

• Provide QA oversight of QC activities.
• Review and approve QC method validation, equipment qualification, protocols, reports, process control documents, and new/existing procedures.
• Support evaluation and resolution of QC deviations and investigations; contribute to process improvement initiatives.
• Position is full-time with standard hours; commuting distance to Sanford, NC is required.

Conoscenze

GMP Experience

QC Oversight

Method Validation

Equipment Qualification

Change Controls

HPLC/GC Testing

Investigations

Pharmacopoeia knowledge

Formazione

BS or BA in a related field

Descrizione del lavoro

Company Description

Eurofins 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 laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

Company Description

Eurofins 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 laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

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

• Responsible for providing Quality Assurance (QA) oversight of Quality Control (QC) activities
• QA review and approval of QC method validation, equipment qualification, protocols, reports, process control documents, and both new and existing procedures
• Support the evaluation and resolution of QC deviations and investigations, and contribute to the implementation of process improvement initiatives
  
  

The site is not accesible by public transportation routes.

Qualifications

• BS or BA degree Scientist or related field with a minimum of 4 years of experience in manufacturing, laboratory, quality, technical or engineering experience within biotech or the pharmaceutical industry
• GMP Experience required
• Direct experience needed with: Method Transfer Validation, Investigation, Authoring Change Controls, Equipment Qualification
• Experience with testing and execution of assays such as HPLC, GC, raw materials testing
• Ability to understand and drive process improvements
• Pharmacopia experience preferred
• Authorization to work in the United States indefinitely without restriction
  
  

Additional Information

Position is full-time, Monday-Friday 8am-5pm with overtime as needed. Candidates currently living within a commutable distance of SANFORD, NC are encouraged to apply. This site is not accessible by public transportation options; daily, reliable transportation is needed to and from the site.

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 USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.