ABL, Inc.
ABL, Inc. is an Equal Opportunity Employer and is committed to embracing diverse backgrounds. ABL, Inc. does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, sexual orientation or any other characteristic protected by federal, state or local law. For more information click here.
Job Title
QC Lab Coordinator I
Location
Rockville, MD 20850 US (Primary)
Job Type
Full-time
Funding available in current budget
$65k+
Exemption Type
Exempt
Career Level
Entry Level
Education
High School Diploma / GED
Job Description
The Quality Control Laboratory Coordinator I will oversee and coordinate activities of the Quality Control group. These activities may include ordering, shipping, GMP release, and receiving materials and/or biological samples. Additionally, the QC lab coordinator may work on documents to support QC activities in support of biopharmaceuticals (vaccines, biologics, viral vaccines, monoclonal antibodies, etc). Receive and login in samples by assigning a unique quality control accession number QCA (cGMP) or QCN (non-GMP). Prepare sample shipment per assigned sampling plan to external labs. Complete sample submission forms and coordinate with external vendors. Liaise with internal stakeholders (Technical and Project Management) to communicate sample testing timeline and receipt of results. Liaise with Quality Assurance and Project Management to provide product test results. Perform and maintain sample inventory lists in controlled temperature units at various temperatures. Perform release of incoming GMP supplies (complete paperwork, collect sample aliquots If needed, label materials for release). Assist with the generation of new material specification documents for new materials. Assess par levels of labs supplies and assist with ordering materials. Assess par levels of office supplies and assist with ordering materials. Enter environmental monitoring data into trending spreadsheets. Support visual inspection (vial inspection, labeling, requesting paperwork, etc). Receive the necessary vaccines required to work on various projects Cross train (once core job activities are completed) to provide support to other teams within the QC organization. Other duties as assigned
Job Requirements
High School diploma with a minimum of 2-3 years of experience with material management and shipping Previous lab experience is preferred. The incumbent must be able to work independently, with general guidance and supervision. Ability to liaise and work with different personalities. This position requires interaction with shipping and receiving, Manufacturing and Process Development departments and with outside vendors. Work output is expected to maintain quality standards consistent with quality policies and all applicable federal regulations. Flexible work hours may be required to support manufacturing schedules. Excellent oral and written interpersonal communication skills. High attention to detail, excellent organizational skills and the ability to work on multiple projects with tight deadlines. Proven and demonstrated computer (PC) and software skills including instrument software, MS Office Suite programs, Internet, email systems. Strong communication Possess managerial courage to multitask Takes initiative Works well with all types of people Remains calm under pressure
Travel Expectation
ABL, Inc. participates in E-Verify, an Internet-based system of the Department of Homeland Security (DHS) and Social Security Administration, that allows us to determine an employee's eligibility to work in the United States.
ADDITIONAL INFORMATION:
Candidate must meet all the requirements of our Company Occupational Health program as directed by the Occupational Health Consultant to include pre-employment physical and drug screen. Candidates are encouraged to submit a resume and a cover letter outlining background and experience as it relates to the position requirements and salary history/requirements. Please note that "negotiable" is neither salary nor requirements. Salary commensurate with experience.
ABL, Inc. does not accept nor respond to unsolicited resumes from vendors, including recruitment agencies and search firms. Approved recruiting agencies must obtain prior approval from ABL, Inc. Human Resources in order to submit resumes to ABL, Inc. for consideration.
Job Title
QC Lab Coordinator I
Location
Rockville, MD 20850 US (Primary)
Job Type
Full-time
Funding available in current budget
$65k+
Exemption Type
Exempt
Career Level
Entry Level
Education
High School Diploma / GED
Job Description
The Quality Control Laboratory Coordinator I will oversee and coordinate activities of the Quality Control group. These activities may include ordering, shipping, GMP release, and receiving materials and/or biological samples. Additionally, the QC lab coordinator may work on documents to support QC activities in support of biopharmaceuticals (vaccines, biologics, viral vaccines, monoclonal antibodies, etc). Receive and login in samples by assigning a unique quality control accession number QCA (cGMP) or QCN (non-GMP). Prepare sample shipment per assigned sampling plan to external labs. Complete sample submission forms and coordinate with external vendors. Liaise with internal stakeholders (Technical and Project Management) to communicate sample testing timeline and receipt of results. Liaise with Quality Assurance and Project Management to provide product test results. Perform and maintain sample inventory lists in controlled temperature units at various temperatures. Perform release of incoming GMP supplies (complete paperwork, collect sample aliquots If needed, label materials for release). Assist with the generation of new material specification documents for new materials. Assess par levels of labs supplies and assist with ordering materials. Assess par levels of office supplies and assist with ordering materials. Enter environmental monitoring data into trending spreadsheets. Support visual inspection (vial inspection, labeling, requesting paperwork, etc). Receive the necessary vaccines required to work on various projects Cross train (once core job activities are completed) to provide support to other teams within the QC organization. Other duties as assigned
Job Requirements
High School diploma with a minimum of 2-3 years of experience with material management and shipping Previous lab experience is preferred. The incumbent must be able to work independently, with general guidance and supervision. Ability to liaise and work with different personalities. This position requires interaction with shipping and receiving, Manufacturing and Process Development departments and with outside vendors. Work output is expected to maintain quality standards consistent with quality policies and all applicable federal regulations. Flexible work hours may be required to support manufacturing schedules. Excellent oral and written interpersonal communication skills. High attention to detail, excellent organizational skills and the ability to work on multiple projects with tight deadlines. Proven and demonstrated computer (PC) and software skills including instrument software, MS Office Suite programs, Internet, email systems. Strong communication Possess managerial courage to multitask Takes initiative Works well with all types of people Remains calm under pressure
Travel Expectation
ABL, Inc. participates in E-Verify, an Internet-based system of the Department of Homeland Security (DHS) and Social Security Administration, that allows us to determine an employee's eligibility to work in the United States.
ADDITIONAL INFORMATION:
Candidate must meet all the requirements of our Company Occupational Health program as directed by the Occupational Health Consultant to include pre-employment physical and drug screen. Candidates are encouraged to submit a resume and a cover letter outlining background and experience as it relates to the position requirements and salary history/requirements. Please note that "negotiable" is neither salary nor requirements. Salary commensurate with experience.
ABL, Inc. does not accept nor respond to unsolicited resumes from vendors, including recruitment agencies and search firms. Approved recruiting agencies must obtain prior approval from ABL, Inc. Human Resources in order to submit resumes to ABL, Inc. for consideration.