À propos
Overview:
We are seeking a
Test QA Specialist
to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland.
PBF is a one-of-a-kind cGMP-compliant pharmaceutical manufacturing facility engaging in next-generation development for cutting-edge companies and government agencies. The professionals at PBF are engaging in trailblazing endeavors every day. Most exciting, the end products vary, so every year brings multiple opportunities for professional enrichment in original projects.
CAMRIS International, LLC, is a dynamic medical research and development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today's most effective, evidence-based best practices. Our core practice areas include vaccine research, development, and production; microbiology and infectious disease research; biodefense; clinical research; global health security; and HIV/AIDS programs.
Our employees enjoy a collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.
Responsibilities:
Control all critical GMP materials, including raw materials, components, in process material and final product (including receipt, storage, disposition, destruction and shipping.)
Control physical movement between stages and complete associated documentation to substantiate movement of materials.
Update all documentation and tracking information periodically (spreadsheets, database logs, etc.) to accurately reflect physical inventory of materials following cGMP's.
Report inventory discrepancies to Quality Systems Manager and assist in resolving, documenting and performing corrective action.
Verify that all labeling of materials is correct and generate and apply labels reflecting material information and status.
Interact with building monitoring system to ensure storage conditions of materials remain in control.
Notify Section Heads if material storage equipment fails.
Provide service to Production Personnel, CRADA partners, and Primary Investigators to ensure that raw materials and product are supplied in a controlled and timely manner.
Back up other Quality Assurance staff members as needed.
Provide assistance to CRM Headquarters as needed on proposal writing projects and provide assistance with all job-related progress reports/technical reports.
Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer.
Performs light duties and other related duties as required and assigned.
Qualifications:
Must have at least a BS/BA degree.
Must have 3 years of employment at a Biotechnology, Pharmaceutical or related facility.
Must have a minimum of 4 years' experience in the Quality Assurance and/or Inventory field.
Requires a full understanding of Quality Assurance from a Biotechnology, Pharmaceutical or related facility and GMP and regulatory training. Must be familiar with Microsoft Office.
Required Knowledge, Skills and Abilities: knowledge of applicable highly complex office procedures and techniques relating to position.
Work Environment: office environment; may require working evenings and weekends.
Must be able to work independently following a brief period of specific technical training.
Physical Requirements:
The physical requirements, workplace hazards and conditions, and PPE and chemical requirements described here are representative of those that a candidate must meet to perform the essential functions of this job. Reasonable accommodation may be provided to enable individuals with disabilities to perform essential job functions.
Physical Demands
Constantly conduct sedentary work that primarily involves sitting/standing.
Occasionally conduct light work that includes moving objects up to 20 pounds.
Occasionally push or pull less than 25 pounds, or push or pull 25 – 45 pounds.
Occasionally reach above shoulder level.
Constantly use both hands.
Occasionally stand or walk for more than 25 minutes.
Occasionally bend, reach, or twist repeatedly.
Occasionally kneel, squat, or stoop.
Constantly have clear vision (near and/or far), depth perception, peripheral vision, and/or visual acuity.
Physical Activities
Occasionally ascend or descend ladders, stairs, scaffolding, ramps, poles, and the like.
Occasionally move about to accomplish tasks or move from one worksite to another.
Constantly communicate with others to exchange information.
Constantly assess the accuracy, neatness, and thoroughness of the work assigned.
Environmental Conditions
Occasionally work in noisy environments.
Occasionally work in small and/or enclosed spaces.
Constantly work in environments where no adverse environmental conditions are expected.
Please submit your resume online at
www.CAMRIS.com
. CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.
CAMRIS offers a comprehensive benefits package, including medical, dental, and vision insurance for individuals and families, FSAs, HSA, life and AD&D insurance, short- and long-term disability, legal services, voluntary hospital indemnity, critical illness and accident insurances, EAP, pet insurance, 401(k) with employer match and Roth option, tuition and professional reimbursement, public transportation support in the DMV area, a referral bonus program, vacation with tenure-based increases, PTO, 11 paid holidays, paid bonding leave, and paid supplemental short-term disability.
Employment is contingent upon successful completion of a Public Trust-level background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment, education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding.
Compétences linguistiques
- English
Avis aux utilisateurs
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