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Maxim Biomedical is a cGMP FDA Approved facility located in Rockville MD. Maxim manufactures a variety of HIV diagnostic products. Currently we are in development of products of other disease states. Maxim is a small team oriented company. You will have the opportunity to learn a lot while working across different functional areas.
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Job Snapshot: Send your resume to joema@mbidiagnostic.com with applying position.
Position:
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Manufacturing Assistant
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Specialty:
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Medical Device Manufacturing
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Gender:
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No Restriction
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Employee Type:
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Full Time
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Work Location:
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Rockville
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Education:
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> High School |
Requirement:
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Working experience up to 3 year(s)
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Duties & Requirements:
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Duties:
• Operate automated EIA plate coating and heat sealing equipment
• Print labels and label components by hand and by using an automated label machine
• Assemble and inspect kits as schedule following SOPs
• Clean, calibrate, and maintain laboratory equipment
• Clean glassware, autoclave equipment and waste as necessary
• Properly package and dispose of hazardous waste
• Clean, calibrate, and maintain laboratory equipmentent
• Maintain accurate production documents, lab records, and log books
• Follow Good Manufacturing (GMP), Quality System Regulation (QSR), and safety regulations
• Assist Product Technology with validations
• Write and revise written procedures (Standard Operating Procedures (SOP), Manufacturing Procedures (MP)) as necessary
• Support kit assembly and packaging operations, as well as Gel production, when required
• Other duties as assigned
Requirements
• BS/BA degree in the biosciences or related experience.
• Ability to operate basic laboratory equipment
• Knowledge of basic laboratory techniques.
• Knowledge of sterile filtration and aseptic technique
• Ability to work both independently and as part of a team
• Ability to organize and prioritize workload to meet production schedule
• Good oral, written, and laboratory math skills
• Working knowledge of QSRs and GMPs.
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Job Snapshot: Send you resume to joema@mbidiagnostic.com with applying position.
Position:
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Quality Assurance Manager
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Specialty:
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Medical Device Quality Assurance Experience
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Gender:
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No Restriction
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Employee Type:
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Full Time
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Work Location:
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Rockville
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Education:
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> B.S. in Biological studies or equivalent education or experience
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Requirement:
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QA related Working experience >3 years
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Duties & Requirements:
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Duties:
• Ensure the facility is compliant with all applicable regulation including Quality System Regulations (QSR), current Good Manufacturing Practice (cGMP), ISO and other regulations where applicable.
• Oversee the Quality Assurance (QA) department's activities including management review, calibrations, validations, preventative maintenance, complaints, techinical services, final release, CAPA's, NCR's, NCI's and internal/external audits and other QA activities.
• Oversee the document control center and staff.
• Interact with Regulatory Agencies.
• Participate as needed in failure investigations and preventative and corrective action plans to address quality issues.
• Establish and maintain quality trending reports such as CAPA’s, NCR’s, NCI’s, and monthly report, etc.
• Work closely with all areas to ensure quality processes are maintained and supported.
• All QA duties and other duties as assigned
Requirements
• Experience in QA in the biotech industry and medical device preferred.
• QA experience in complaint handling, technical services and familiar with ISO, GMP, GLP, FDA, CFR (medical device) and OSHA regulations.
• Ability to work independently or as part of a team.
• Ability to prioritize, lead teams, coordinate investigations and strong analytic skills in determining quality problems and developing solutions.
• Ability to schedule and handle multi-tasking to meet deadlines.
• Effective written communication skills, understanding of good documentation practices.
• Good clerical, math and computer skills. Knowledge of MS office suite (Words, Excel, Powerpoint, Access).
• Good reading, writing, and speaking skills.
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Job Snapshot: Send your resume to joema@mbidiagnostic.com with applying position.
Position:
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QC Technician |
Specialty:
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Quality Control Analyst
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Gender:
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No Restriction
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Employee Type:
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Full Time
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Work Location:
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Rockville
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Education:
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> B.S.
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Requirement:
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Working experience up to 5 year(s)
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Duties & Requirements:
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Duties:
• Follow Good Manufacturing Practice (GMP)/Good Laboratory Practice (GLP), Quality Systems Regulation (QSR), Environmental Protection Agency (EPA) and safety regulations in an FDA licensed facility..
• Maintain accurate laboratory logbooks and testing documentation, per established procedures..
• Assist in keeping procedures current to QSR guidelines as established by the FDA.
• Evaluate materials by way of Western Blot, Microbial/Sterility, Infectivity and general chemical analysis testing methods.
• Evaluate environmental conditions (Surface and Air) per USP and FDA guidelines.
• Assist in the generation and revision of Standard Operating Procedures (SOP).
• Assist in the generation and implementation of validation protocols.
• Conduct stability testing per established protocols, as well as assist in the generation of stability protocols.
• Conduct complaint investigation testing when requested by Supervisor.
• Work closely with all areas to ensure quality processes are maintained and supported.
• Perform incoming inspection and test and subsequent approval of received materials
• Review batch history records for accuracy and completeness.
• Assist in QC analyst training and other additional duties as assigned.
Requirements
• B.S. in Biological studies or equivalent education or experience.
• Good clerical, math and computer skills. Knowledge of MS Excel and MSW.
• Good reading, writing, and speaking skills.
• Manual dexterity.
• Knowledge of GMP and GLP.
• Ability to work independently and as part of a team.
• Ability to follow written protocols.
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Job Snapshot: Send your resume to sunyi@mbidiagnostic.com with applying position.
Position:
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Facility Inventory Assistant |
Specialty:
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Calibration, inventory control |
Gender:
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No Restriction
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Employee Type:
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Full Time
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Work Location:
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Rockville
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Education:
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> High School
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Requirement:
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Working experience up to 5 year(s)
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Duties & Requirements:
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Duties:
• Receives, processes, and stores inbound materials in assigned locations.
• Receives and stores manufactured materials in assigned locations.
• Issues inventory and non-inventory items to end users.
• Process and dispose of scrap inventory.
• Perform cycle counts as required.
• Process customer orders and package finished product for shipment.
• Ship all sales orders on time or as directed by customer service.
• Post accountability documents for materials processed, issued, scrapped, or shipped.
• Follow all Good Manufacturing Practice (GMP), Quality System Regulation (QSR), Standard Operating Procedure (SOP), and safety regulations.
• Responsible for performing calibrations and Preventive Maintenance (PM).
• Other general materials and production duties as assigned.
• All other duties as assigned.
Requirements
• High School Diploma, B.S or B.A preferred.
• 2-3 years of materials handling experience
• Good computer skills in a Windows98/Windows NT environment, MS Office familiarity preferred
• Experience handling hazardous materials - medical, chemical, pharmaceutical, or biotech industry preferred.
• Good written, oral, and basic math skills.
• Ability to follow written procedures and work independently from them.
• Ability to interact with peers.
• Good interpersonal and teamwork skills.
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