Quality Assurance - Scientist I - Data Reviewer
The Company:
Pace Life Sciences (PLS) is an industry leading contract lab supplying analytical chemistry and microbiology services to the Medical Device, Pharmaceutical, and Life Sciences industry. Since our formation in 2006 we have grown at a rate of over 15% per year and established ourselves as one of the top ten contract laboratories within the United States providing cGMP services to a wide range of clients worldwide. We attribute our rapid growth to our solid quality system combined with an exceptional culture of client service
Summary:
We are actively seeking a candidate to join our Quality Assurance (QA) Data Review team as an Scientist I. This is a non-laboratory position - office position. The ideal candidate is one who thrives working in a highly dynamic, team- oriented environment sharing the common goal of providing our clients with the information they need to improve the safety and effectiveness of materials produced and used in pharmaceutical and medical device products.
The QA Scientist I - Data Reviewer is responsible for review of laboratory technical records. Technical records can be documented in worksheets or electronically. Laboratory activities vary from routine, compendia type analyses to more complex client specific chromatographic methods, in support of testing pharmaceutical and medical device products. The QA Data Reviewer reports to the QA Group Leader.
The ideal candidate is self-guided and highly motivated, demonstrating a strong sense of self-initiative and flexibility, a desire to collaborate with all departments and an interest in continuing to acquire new knowledge and skills.
Preferred qualifications include either GMP laboratory or data review experience in wet chemistry techniques and spectrophotometric techniques, such as UV-VIS, liquid chromatography, gas chromatography, mass spectrometry including LC-MS, ICP-MS and GC-MS, Waters Empower Chromatography Data System, and other general laboratory techniques. If the candidate has experience with method development, method validation, and method transfers that would be ideal.
Job Responsibilities:
· Perform review of laboratory technical records while ensuring that client due dates are met.
· Provide support to other members of the QA Data Review Team.
· Review and approve final analysis reports.
· Develop and maintain computer skills related to work performed, including familiarity with laboratory computer applications (e.g., ELN, LIMS, Waters Empower Chromatography System).
· Assure all work performed is compliant with Pace Analytical Life Sciences SOPs and GMP requirements.
· Become familiar and regularly updated with quality and regulatory policies associated with the technical area.
· Participate in quality, cGMP, safety, method and technique training appropriate for their area.
· Other tasks as assigned by QA Group Leader
Requirements:
· Keen attention to detail and adherence to SOPs and Good Documentation Practices within a cGMP environment
· Strong interpersonal skills
· Strong verbal and written communication skills
· Ability to excel in a fast-paced work environment
· Ability to work independently, multi-task and be flexible with changing priorities
· Bachelor’s Degree in Chemistry preferable
· Seven years minimum of laboratory experience, preferably in FDA regulated laboratory environment
· Empower experience is preferred
Physical/Mental Requirements:
The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Mobility to work in an office setting, use standard office equipment and stamina to sit for extended periods of time; strength to lift and carry up to 10 pounds; vision to read printed materials and computer screens; and hearing and speech to communicate in person or over the telephone.
Working Environment:
Work is performed in a lab and office setting. Work is subject chemicals, fumes, gasses, noxious odors and related items in a lab setting.
OFCCP Statement
Pace Analytical is an Equal Opportunity Employer and will not discriminate against any applicant for employment on the basis of race, age, religion, sex, veterans, individuals with disabilities, sexual orientation, or gender identity.
This role is working Monday through Friday 8:00am to 5:00pm onsite and in the office. From time to time this role will require coming in early, staying late, and occasional weekend work as needed.