QA Associate

Top Skills:
GMP
5-7 years of QA experience in industry
QA documentation

JOB SUMMARY: Responsible for providing Quality Assurance support to Manufacturing Operations relative to the production of commercial and/or clinical products. Responsible for a diverse and challenging set of activities, all of which are related to maintaining quality standards aligned with US FDA cGMP, QSR, ISO and other applicable international regulations and guidance documents.

ESSENTIAL FUNCTIONS: (Include percentage of time for each)
1. Performs in-process checks and inspections; review batch records to ensure that all steps have been performed and verified where applicable, that all limits and specifications have been met and the raw materials and solutions have been tested and released through incoming and in-process inspection process. (35%)
2. Performs incoming inspections on components and raw materials; and send samples to external testing laboratories (where appropriate). Verify that all limits and specifications have been met. (25%)
3. Perform complaint investigations through analyzing returns and reviewing batch records. Provide written reports of findings. (10%)
4. Maintains the Calibration program, distributes monthly calibration reports and sends items to external calibration sources. (5%)
5. Maintains the CAPA program, manages monthly CAPA meetings and distributes minutes from the meetings. (5%)
6. Conducts environmental monitoring sampling & testing. (5%)
7. Participates in compliance audits (internal and external) and correct deficiencies as required through the appropriate system. (5%)
8. Performs other related duties as assigned by management. (10%)
SKILLS & ABILITIES: (Include job complexity, judgment, physical and visual demands)
 Must have strong verbal, written and mathematical skills.
 Must be flexible in terms of working hours to meet requirements of position.
 Must be able to wear safety glasses/goggles and other personal protection as required for entry and work in the manufacturing facilities. Be able to tell color differences/have normal color vision.
 Must have experience performing inspections and investigations.
 Demonstrated proficiency with Microsoft Word, Microsoft Excel, and Microsoft Outlook programs.

About Aerotek:

Our people are everything. As a Best of Staffing® Client and Talent leader, Aerotek® Inc. has distinguished itself as a leader in recruiting and staffing services, by having a deep understanding of the intersection of talent and business. As a strategic partner to more than 17,000 clients and 300,000 contract employees every year, Aerotek's people-focused approach yields competitive advantages for its clients and rewarding careers for its contract employees. Headquartered in Hanover, Md., Aerotek operates a network of over 230 non-franchised offices with more than 6,000 internal employees dedicated to serving our customers. Aerotek is an operating company of Allegis Group, a global talent solutions provider. To learn more, visit .

Aerotek is acting as an Employment Agency in relation to this vacancy.