What are the responsibilities and job description for the Quality Control Technician position at BioBridge Global?
BBG Advanced Therapies is a full-service biomanufacturing organization that delivers comprehensive, cell and cell-based manufacturing solutions for advanced therapies. Leveraging its showcase facility designed to be compliant with FDA, EMEA, and PMDA production requirements, BBG Advanced Therapies focuses on translating and refining early-stage processes to scale for commercial readiness.
Job Title: Quality Control Technician
Revision: 0000
Job Code: 703764
Shift: M-F Day Shift
FLSA: OT Eligible
Hybrid? N
CPF Level: TB2
Location: San Antonio, TX
Dept.: Global Quality and Compliance
Business Unit: BioBridge Global Advanced Therapies
Summary
General Summary
Responsible for completing assigned Quality Control QC processes, programs and to conduct QC activities. This position is responsible for ensuring compliance in all stages of product or sample testing and review; as well as performing QC testing on in-process, product, stability and/or research samples and other operational activities. This position will identify continuous process improvement areas, in compliance with GMP processes and documentation for quality control activities. Requires excellent technical skills and abilities, analytical and mathematical skills, organizational and time-management skills, verbal and written communication skills, as well as the ability to apply attention to detail.
Commit to and abide by the character of BioBridge Global’s Core Values of Accountability, Stewardship, Pioneer, Integrity, Respect and Excellence (ASPIRE). Support, communicate and reinforce the mission and vision of the enterprise.
Provide world class customer service by capturing and being responsive to the voice of the customer (internal or external, including donors for select positions) through multiple feedback channels in order to resolve issues and drive satisfaction in accordance with the BBG customer engagement, feedback, and complaint processes.
Responsibilities
Major Duties and Responsibilities
Essential Tasks
Reviews documentation, including records, procedures, and forms to ensure quality endpoints and compliance requirements are achieved.
Conduct sampling and testing in support of the environmental monitoring at BBG-AT.
Actively contribute to data relevant to Quality Systems Compliance in periodic Management Review meetings.
Assists Quality Management in coordinating and actively participating in Quality or Compliance related projects.
Conduct Product Tests and Assessment in an industrial or warehouse setting to ensure that specifications are met, and that the product, material, or supply will function as intended.
Perform in-process and final product/result inspections and clearances on the production floor to ensure consistency.
Identify product defects or potential issues and determining what to do to resolve the issue.
Analyze the results of lab or usability tests to identify these defects and make sure they do not persist.
Maintain detailed records of product defects or manufacturing issues as they test and assess products to help identify and eliminate recurring problems and provide a paper trail to aid in accountability and error reporting.
Notify of issues or defect reports to supervisors or plant managers to help them make decisions about manufacturing processes and practices.
Support process improvements throughout the testing and quality assurance processes.
Suggest improvements to address potential systemic problems found during quality control, to ensure that products are produced consistently, and that defects or other errors will not persist throughout the manufacturing or testing process.
Performs other duties as assigned.
Non-Essential Tasks
Assist other departments as assigned.
Education
Requires a high school diploma or general equivalency diploma.
Prefer sixty (60) hours from an accredited college or university or Associate Degree from an accredited college or university.
Experience
Requires three years or more Quality Control experience, preferrable in microbiology, in regulated environment or other job-related experience.
If Associate's Degree is attained, requires a minimum of 1 years of Quality Control related experience.
Knowledge
Must have a working knowledge and understanding of FDA regulations and current Good Manufacturing Practices (cGMPs).
Must acquire a working knowledge of all administrative aspects of document control operations and eQMS.
Must maintain knowledge of ISO Standards, cGMP (current Good Manufacturing Practices) and regulatory
requirements concerning creation and maintenance of controlled documents and record retention.
Must have working knowledge of a microbiology laboratory.
Must have working understanding of aseptic or sterile behavior and techniques. Must have a working knowledge of various LIS software programs.
Skills
Must have excellent written and oral communication skills. Must have excellent telephone and/or email etiquette skills.
Must have experience using Microsoft Office applications including Word, Outlook, Visio, PowerPoint and Excel. Must have strong computer skills.
Abilities Must be able to keep information confidential Must be neat in appearance and well groomed.
Must be professional, detail oriented, self-motivated, innovative, creative, assertive, organized, communicative, and have the ability to work independently.
Must have the ability to answer telephones and greet the public in a friendly and courteous manner
Must maintain good working rapport with all departments.
Working Environment
Works in a well-lighted air conditioned and heated laboratory/department.
May be exposed to electrical, mechanical and chemical hazards and other conditions common to a laboratory environment.
May be exposed to blood borne pathogens and other conditions common to a clinical laboratory environment.
May have bodily exposure to refrigerator/freezer temperature, especially hands and face. Will work extended hours during peak periods.
May be required to work any time of the day, evening or night during the week or weekend.
Occupational Exposure Assignment - Category I
We invest in our people by offering competitive compensation, excellent benefits, and the opportunity to work with the first blood center in America to receive the ISO 9002 accreditation!
All Full Time Positions Qualify for an Affordable and Competitive Benefits Package to include:
Job Title: Quality Control Technician
Revision: 0000
Job Code: 703764
Shift: M-F Day Shift
FLSA: OT Eligible
Hybrid? N
CPF Level: TB2
Location: San Antonio, TX
Dept.: Global Quality and Compliance
Business Unit: BioBridge Global Advanced Therapies
Summary
General Summary
Responsible for completing assigned Quality Control QC processes, programs and to conduct QC activities. This position is responsible for ensuring compliance in all stages of product or sample testing and review; as well as performing QC testing on in-process, product, stability and/or research samples and other operational activities. This position will identify continuous process improvement areas, in compliance with GMP processes and documentation for quality control activities. Requires excellent technical skills and abilities, analytical and mathematical skills, organizational and time-management skills, verbal and written communication skills, as well as the ability to apply attention to detail.
Commit to and abide by the character of BioBridge Global’s Core Values of Accountability, Stewardship, Pioneer, Integrity, Respect and Excellence (ASPIRE). Support, communicate and reinforce the mission and vision of the enterprise.
Provide world class customer service by capturing and being responsive to the voice of the customer (internal or external, including donors for select positions) through multiple feedback channels in order to resolve issues and drive satisfaction in accordance with the BBG customer engagement, feedback, and complaint processes.
Responsibilities
Major Duties and Responsibilities
Essential Tasks
Reviews documentation, including records, procedures, and forms to ensure quality endpoints and compliance requirements are achieved.
Conduct sampling and testing in support of the environmental monitoring at BBG-AT.
Actively contribute to data relevant to Quality Systems Compliance in periodic Management Review meetings.
Assists Quality Management in coordinating and actively participating in Quality or Compliance related projects.
Conduct Product Tests and Assessment in an industrial or warehouse setting to ensure that specifications are met, and that the product, material, or supply will function as intended.
Perform in-process and final product/result inspections and clearances on the production floor to ensure consistency.
Identify product defects or potential issues and determining what to do to resolve the issue.
Analyze the results of lab or usability tests to identify these defects and make sure they do not persist.
Maintain detailed records of product defects or manufacturing issues as they test and assess products to help identify and eliminate recurring problems and provide a paper trail to aid in accountability and error reporting.
Notify of issues or defect reports to supervisors or plant managers to help them make decisions about manufacturing processes and practices.
Support process improvements throughout the testing and quality assurance processes.
Suggest improvements to address potential systemic problems found during quality control, to ensure that products are produced consistently, and that defects or other errors will not persist throughout the manufacturing or testing process.
Performs other duties as assigned.
Non-Essential Tasks
Assist other departments as assigned.
Education
Requires a high school diploma or general equivalency diploma.
Prefer sixty (60) hours from an accredited college or university or Associate Degree from an accredited college or university.
Experience
Requires three years or more Quality Control experience, preferrable in microbiology, in regulated environment or other job-related experience.
If Associate's Degree is attained, requires a minimum of 1 years of Quality Control related experience.
Knowledge
Must have a working knowledge and understanding of FDA regulations and current Good Manufacturing Practices (cGMPs).
Must acquire a working knowledge of all administrative aspects of document control operations and eQMS.
Must maintain knowledge of ISO Standards, cGMP (current Good Manufacturing Practices) and regulatory
requirements concerning creation and maintenance of controlled documents and record retention.
Must have working knowledge of a microbiology laboratory.
Must have working understanding of aseptic or sterile behavior and techniques. Must have a working knowledge of various LIS software programs.
Skills
Must have excellent written and oral communication skills. Must have excellent telephone and/or email etiquette skills.
Must have experience using Microsoft Office applications including Word, Outlook, Visio, PowerPoint and Excel. Must have strong computer skills.
Abilities Must be able to keep information confidential Must be neat in appearance and well groomed.
Must be professional, detail oriented, self-motivated, innovative, creative, assertive, organized, communicative, and have the ability to work independently.
Must have the ability to answer telephones and greet the public in a friendly and courteous manner
Must maintain good working rapport with all departments.
Working Environment
Works in a well-lighted air conditioned and heated laboratory/department.
May be exposed to electrical, mechanical and chemical hazards and other conditions common to a laboratory environment.
May be exposed to blood borne pathogens and other conditions common to a clinical laboratory environment.
May have bodily exposure to refrigerator/freezer temperature, especially hands and face. Will work extended hours during peak periods.
May be required to work any time of the day, evening or night during the week or weekend.
Occupational Exposure Assignment - Category I
We invest in our people by offering competitive compensation, excellent benefits, and the opportunity to work with the first blood center in America to receive the ISO 9002 accreditation!
All Full Time Positions Qualify for an Affordable and Competitive Benefits Package to include:
- Competitive salary
- 100% Employer Paid Life Insurance
- 401(k) with Employer Contribution
- 100% Employer Paid Long-term Disability Plan
- Paid Time Off (PTO)
- 100% Employer Paid AD&D
- Extended Illness Benefits (EIB)
- 100% Employer Paid Employee Assistance Program
- Incentive Compensation Plan
- Group Health Medical Plan with prescription coverage
- Shift Differentials
- Variety of Voluntary Supplemental Insurances
- Paid Holidays
- Voluntary Dental Coverage
- Educational Assistance Program
- Voluntary Vision
