QA Chemistry Data Review Specialist
Pace Analytical 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 10% 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.
We are actively seeking an experienced candidate to join our Quality Assurance (QA) Data Review team. This is a non-laboratory 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 Data Review Specialist is responsible for review of chemistry laboratory technical records. Technical records can be documented in worksheets or in an electronic laboratory notebook. Laboratory activities include general wet chemistry techniques, UV/VIS, FTIR, Total Organic Carbon (TOC), Inductively Coupled Plasma with Optical Emission Spectroscopy (ICP/OES) or Mass Spectroscopy (ICP-MS), Atomic Absorption (AA), Liquid Chromatography (HPLC) with various detectors (e.g. PDA, MS), Gas Chromatography (GC) with various detectors (e.g. PID, FID, MS), Karl Fisher titrations among other analysis.
The ideal candidate is highly motivated, with strong attention to detail, and demonstrates self-initiative, flexibility, a desire to collaborate with all departments and an interest in continual improvement.
Candidate(s) may be expected to perform job-related duties other than those listed below.
1. Review the following types of chemistry laboratory technical records with strong attention to detail, while ensuring that client due dates are met:
- General wet chemistry techniques
- Spectrophotometric techniques (e.g. UV/VIS, Atomic Absorption (AA), Inductively Coupled Plasma with Optical Emission Spectroscopy or Mass Spectroscopy)
- Gas Chromatography (GC)
- Liquid chromatography (HPLC)
- Karl Fisher Titrations
2. Review and approve final analysis reports.
3. Provide support and guidance to other members of the QA Data Review Team.
4. Assure all work performed is compliant with Pace Analytical Life Sciences SOPs and cGMP requirements.
5. Apply quality and regulatory standards and guidelines (e.g. FDA cGMP, ICH) associated with the technical area.
6. Participate in quality, cGMP, safety, SOP and technical records review training, as applicable and as assigned.
7. Promote and support the overall mission of Pace Analytical by demonstrating courteous and cooperative behavior when interacting with clients (internal and external); act in a manner that promotes a harmonious and effective workplace environment.
To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required and desired.
EDUCATION AND EXPERIENCE
Bachelor’s degree (BA/BS) in chemistry or other relevant Life Science discipline; AND two (2) years of laboratory or quality assurance data review experience, preferably in an FDA regulated industry (e.g. medical device, pharma, biotech); OR an equivalent combination of education, training and experience.
REQUIRED/DESIRABLE KNOWLEDGE AND SKILLS
Required Knowledge and Skills
- A minimum of two (2) years of experience working in a cGMP testing laboratory.
- Familiarity with FDA cGMPs and thorough understanding of Good Documentation Practices.
- Strong attention to detail and adherence to SOPs and Good Documentation Practices within a cGMP environment.
- Experience either performing or reviewing analytical chemistry laboratory techniques.
- Strong technical knowledge in chemistry.
- Strong attention to detail.
- Excellent verbal and written communication skills.
- Ability to excel in a fast-paced work environment.
- Ability to handle multiple tasks concurrently and in a timely fashion.
- Excellent interpersonal skills and ability to work independently and effectively in a team environment to accomplish goals.
- Establish and maintain effective working relationships with a variety of individuals contacted in the course of the work.
- Ability to communicate effectively with both internal and external customers.
- Flexibility and adaptability to manage changing task priorities.
Desirable Knowledge and Skills
- Knowledge with compendia (e.g. United States Pharmacopoeia, European Pharmacopoeia)
- Knowledge of Waters Empower Chromatography Data System
- Experience performing or reviewing chromatography
- Experience performing or reviewing microbiology testing, such as environmental monitoring testing, microbial limits and sterility testing.
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 a lab and office setting, use standard office and lab equipment and stamina to sit for extended periods of time; exerting up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently to lift, carry, push, pull or move objects; vision to read printed materials and computer screens; and hearing and speech to communicate in person or over the telephone.
Work is performed in a lab and office setting. Work is subject chemicals, fumes, gasses, noxious odors and related items in a lab setting. May be required to wear personal protective equipment (PPE).
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, and individuals with disabilities, sexual orientation, or gender identity.
This role is working Monday through Friday from 8:00am to 5:00pm. From time to time coming in early, staying late, or weekend is necessary to meet the needs of our clients.