Quality Control Analyst
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
- Title: Quality Control Analyst I/II
- Location: Harmans, MD
- Industry: Pharmaceutical
- Hours: M-F- 12am - 8:30am, 3rd Shift
- Salary: $26.44hr (Paid Weekly - Benefits Available)
- Employment Type: 6 month Contract
Perform Environmental Monitoring of Grade B-D Cleanrooms, including sampling of viable surfaces, viable air and non-viable particulates in a Phase III/Commercial GMP Manufacturing facility.
Conducts routine sampling and testing of Clean Utilities such as USP water (WFI) and clean steam
Conducts bioburden testing on prepared buffers/solutions, equipment cleaning samples, in-process and release drug product samples.
Ability to isolate and sub-culture microorganisms for identification.
Provides input on SOP revisions and may assist in the creation and editing of protocols
Builds credibility within the lab group by performing high quality work
Works closely with manufacturing and QA to coordinate routine EM, changeover EM, and monitoring to support client campaigns
Performs Aseptic Process Simulations (media fills) and fill/finish monitoring which includes continuous monitoring of air quality, personnel aseptic technique, and environment integrity
Compilation and trending of Environmental Monitoring data for reporting purposes
Report and investigate environmental monitoring excursions.
Effectively communicates results of own work through discussions and documentation with some input from supervisor
Flexibility in following unique campaign requirements that may include off-hour and weekend work
Other duties as assigned
SKILLS & TECHNICAL EXPERTISE:
Self-starter with the ability to produce results in a fast-paced environment to meet client deadlines under minimal supervision
Experience with viable and non-viable Environment Monitoring collection instruments.
Creative individual with outstanding trouble shooting skills
Concentration of aseptic technique and contamination control
Streak plating and microbial identification
Document writing, data interpretation, presentation, statistical analysis and trending a plus
Minimum supervision required on day-to-day activities and accomplished tasks
Escalates problems and factors impacting work performance or completion of assigned tasks to the area supervisor
B.S. or A.S. in a Life Sciences discipline and 1-4 years of relevant experience working in cGMP cleanrooms
Experience working in cGMP Quality Control
Experience with Microsoft Office
Strong attention to detail
Familiarity with Good Manufacturing Practices (cGMP s)
Have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
MEASUREMENT OF PERFORMANCE:
Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors and to contribute to a project team
Dependable and can work with minimal supervision on scheduled tasks
Timeliness and accuracy in completion of projects and documentation (quantity of work)
Contributions to projects beyond general responsibilities (quality of work)
Identification of problem areas affecting operations (knowledge/problem solving)
Offers suggestions for correcting problems and for improving operations
Exercises good judgment in dealing with operational problems
Understanding of theory, rationale behind tasks performed
Demonstrated understanding and adherence to Company policies, safety procedures and the cGMPs
Ability to succeed in a team-oriented environment under very dynamic conditions