Aerotek Quality Assurance Documentation Specialist in Wareham, Massachusetts
Position is responsible for preparation of a variety of technical study reports from raw data produced in the laboratory. Incumbent is also responsible for compiling and incorporating comments from several different sources to produce a draft report suitable to issue to the Study Sponsor. Individual is expected to compile information from several different data books into a study report suitable for supervisory review. Individual is routinely required to effectively verbally communicate with
Study Directors and other staff members regarding study details. Individual must have attention to detail, be skillful in reading and understanding data recorded in a variety of data books, an advanced knowledge of technical terminology and the ability to balance multiple priorities. Employee is required to draft reports for studies in which no standard template is available; employee must assist in developing report templates when needed. Employee must also assist in peer reviews of draft reports for report specialists. Assignments are performed with minimal supervision.
Prepares study reports from data presented in technical format that meets guideline and customer requirements. Compiles and incorporates comments from several different levels of review.
Responsible for tailoring reports using Sponsor specific requirements and/or electronic templates.
Responsible for creating graphic representations of data as needed.
Must be proficient in the use of Microsoft Office and Adobe Acrobat software.
Responsible for performing duties associated with issuing draft/final reports to
Sponsors (printing, copying, send via email or UPS; CORTEX and MDI updates)
Responsible for tracking progress and location of assigned report using CORTEX and updating daily.
Must assist in template development.
Must assist in peer review of draft reports for report specialists.
Additional duties as assigned
Ability to use a collection of data books to produce study reports (written comprehension). Ability to understand all components of report content and combining this with technical understanding of the study, assisting in the development of templates for unique study types (written comprehension, memorizing, discriminating). Ability to work in a fast-paced work environment, prioritizing varied work assignments as directed by supervisor (high productivity). Must be able to interact with all members of staff regarding matters of reporting (oral expression, oral comprehension). Ability to integrate various requirements (Sponsor, reviewing Agency etc.) into standard report formats (discriminating, memorizing). Must be able to understand applicable calculations (mathematical reasoning). Ability to function in an open work environment with frequent disturbances (concentration).
Assist supervisor in streamlining reporting processes as needed.
Preparing scientific summaries/status reports on an as-needed basis at client
Assist with training of new hires, as needed.
Assist in scheduling of report production, as needed
Test case, quality control, Quality assurance, Qa, Document control, Gmp, Sop, Data entry, Audit, glp
Top Skills Details:
Additional Skills & Qualifications:
Bachelors Degree in Sciences (Open to Masters)
2-4 years experience with testing and recording test results (no system required)
Strong understanding and experience in GMP or GLP setting
Attention to detail - reports that they create will be going directly to customers
Position is responsible for conducting protocol review inspections, in-life inspections, data and report audits to assess compliance with pertinent GLPs and ensure study integrity, protocols and SOPs, as assigned in addition to specialized assignments as designated. Performs internal facility audits, develops audit reports, and follows up with management. Position responsibilities also include maintaining audit logs and assisting in special assignments at the request of the QA Manager/Director. Position is responsible for providing training in GLPs to operations staff and junior QAU staff. Individual requires a degree of independent activity and creative thought to adapt and develop new programs to meet special needs. Participates in client audits and facilities inspections. May be delegated in charge of daily activities in absence of Supervisor. Good writing and math skills required. Some travel may be necessary. Requires knowledge of OECD, FDA and EPA GLP, as well as industry standards including FDA guidance standards, and experience in either chemistry or biology.
B.S./B.A. in related sciences and a minimum of 3 years of experience in a quality role in the GLP laboratory or equivalent. In lieu of a degree, a minimum of 5 years of relevant experience is acceptable. Comprehensive knowledge of GLPs and/or other regulations effecting work. Level of proficiency and understanding should allow Associate to train others.
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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