About The Role

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.

Major Duties and Responsibilities

Essential Tasks

Reviews documentation, including records, procedures, and forms to ensure quality endpoints and compliance requirements are achieved.
Actively lead and/or 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 also 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.
Assist other departments as assigned.

Performs other duties as assigned.

Non-Essential Tasks

Assist in other laboratory areas as directed.

Education

Required Minimum Education

Requires a high school diploma or general equivalency diploma.

Preferred Education

Prefer sixty (60) hours from an accredited college or university or Associate Degree from an accredited college or university.
Licenses and/or Certifications

Valid United States Driver’s License

Experience

Required Minimum Experience

Requires one or more years of Quality Assurance or Quality Control experience in regulated environment or other job related experience.
If Associate's Degree is attained, requires no additional Quality related experience.

Preferred Experience

Prefer two or more years of Quality Assurance or Quality Control experience in regulated environment or other job related experience.

Knowledge

If you would like to see a list of Knowledge, Skills or Abilities, please let us know and we can send you a list to look through.

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 obtain a working knowledge of regulatory/quality requirements and perform within all Standard Operating Procedures (SOPs) and policies.

Skills

Must have excellent written and oral communication skills.
Must have experience using Microsoft Office applications including Word, Outlook, Visio, PowerPoint and Excel.
Must be capable of operating motor vehicles in all types of weather conditions.
Must have excellent multi-tasking skills and problem solving skills.

Abilities

Must have the ability to answer telephones and greet the public in a friendly and courteous manner.
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 maintain good working rapport with all departments.

Working Environment & Travel Requirements

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. Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials. Ability to wear personal protective equipment including safety goggles, sterile gown, head cover, mask, safety shoes and gloves. No makeup or jewelry can be worn when working in the cleanroom environment. 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

Physical Requirements

Must be able to drive on behalf of the organization. Will sit, stand, walk, and bend during working hours. Requires ability to reach, lift and carry up to 50 lbs.
Requires manual and finger dexterity and eye-hand coordination.
Requires normal or corrected vision and hearing corrected to a normal range.