Eurofins USA PSS Insourcing Solutions
Data Review Specialist
Eurofins USA PSS Insourcing Solutions, Winston Salem, North Carolina, United States, 27104
Job Description
Data Reviewer responsibilities include, but are not limited to, the following:
Reviews simple routine and non-routine laboratory data for one or more areas according to departmental, corporate and client Standard Operating Procedures, Work Instructions, and/or Forms; read and understand analytical procedures; make sure all work is performed according to ISO17025 guidelines, GLP Regulatory, and GMP Regulatory requirements; Independent auditing of laboratory data to ensure continuous compliance to both the quality system and regulatory requirements.
Maintain the highest level of proficiency in terms of those duties and responsibilities as required by auditors/data reviewers.
Perform mathematical calculations as part of data review.
Interact both directly and indirectly with laboratory staff members to ensure all data reviews are appropriately and efficiently corrected and documented.
Responsible for ensuring the integrity of laboratory data.
Communicate in writing and in person with laboratory personnel and/or with the client in an intelligent and clear manner.
May assist in conducting laboratory investigations, exceptions, planned deviations, and/or corrective and preventative actions.
May assist in training of laboratory personnel.
May assist with Quality and Regulatory Audits and interact directly with auditors.
May assist with Technical Writing and/or Report Writing.
Qualifications:
Bachelor’s degree in chemistry, biology, or other related degree concentration, or equivalent directly-related experience (2 years of directly related industry experience is equivalent to 1 full-time year of college in related major).
Minimum of 2 years of experience in laboratory chromatography analyses, Quality, Regulatory, or related experience.
Experience in a cGMP and/or ISO 17025 environment.
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-motivation, adaptability, and a positive 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 Information:
Position is
Monday- Friday 8:00 am- 5:00 pm . Overtime as needed. Candidates currently living within a commutable distance of Indianapolis, IN 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 is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
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Data Reviewer responsibilities include, but are not limited to, the following:
Reviews simple routine and non-routine laboratory data for one or more areas according to departmental, corporate and client Standard Operating Procedures, Work Instructions, and/or Forms; read and understand analytical procedures; make sure all work is performed according to ISO17025 guidelines, GLP Regulatory, and GMP Regulatory requirements; Independent auditing of laboratory data to ensure continuous compliance to both the quality system and regulatory requirements.
Maintain the highest level of proficiency in terms of those duties and responsibilities as required by auditors/data reviewers.
Perform mathematical calculations as part of data review.
Interact both directly and indirectly with laboratory staff members to ensure all data reviews are appropriately and efficiently corrected and documented.
Responsible for ensuring the integrity of laboratory data.
Communicate in writing and in person with laboratory personnel and/or with the client in an intelligent and clear manner.
May assist in conducting laboratory investigations, exceptions, planned deviations, and/or corrective and preventative actions.
May assist in training of laboratory personnel.
May assist with Quality and Regulatory Audits and interact directly with auditors.
May assist with Technical Writing and/or Report Writing.
Qualifications:
Bachelor’s degree in chemistry, biology, or other related degree concentration, or equivalent directly-related experience (2 years of directly related industry experience is equivalent to 1 full-time year of college in related major).
Minimum of 2 years of experience in laboratory chromatography analyses, Quality, Regulatory, or related experience.
Experience in a cGMP and/or ISO 17025 environment.
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-motivation, adaptability, and a positive 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 Information:
Position is
Monday- Friday 8:00 am- 5:00 pm . Overtime as needed. Candidates currently living within a commutable distance of Indianapolis, IN 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 is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
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