At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You’ll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them.

The Quality Engineer I is responsible for assisting in providing quality oversight of equipment as well as computerized system validations and equipment qualifications. He or she is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success and meets business needs.

Essential Responsibilities

- Assist with review and approval of computerized system validations and equipment qualifications.

- Maintain equipment in site QMS

- Ensure equipment is properly labeled, including updating and issuing asset tags and associated maintenance labels are accurate and applied as appropriate.

- Ensure all activities related to maintaining computer systems and equipment within the site QMS follow national/international GxPs as well as 21 CFR Part 11, Annex 11, Annex 15, CLIA and GAMPs

- Perform the quality review of equipment SOPs, policies and validation master plans for equipment implementations, where required

- Review and issue equipment usage and maintenance logbooks

- Assist with the review and approval of validation/qualification documentation for new and existing systems subject to validation/qualification

- Assist with the periodic reviews of validated computerized systems and qualified equipment

- Assist in the review and approval of equipment deviations and out of tolerance investigations

- Assist with decommissioning of validated computerized systems and qualified equipment

- Obtain and maintain professional and technical knowledge by attending educational workshops; review professional publications; establish personal networks

Additional Responsibilities

- Other duties as assigned

Minimum Acceptable Qualifications Education/Experience:

- Bachelor’s degree in science or engineering or related discipline

- Not less than two (2)years’ experience in pharmaceutical/GxP/regulated environment

- Direct hands-on experience with computer systems validation and/or equipment qualifications

- Direct hands-on experience with local/international GxP regulations and industry guidance(FDA, EPA, EU, ICH, USP, ASTM and ISO)

Skills:

- Knowledge of and technical competency in GAMP guidelines and evaluating systems lifecycle principles

- Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company procedures/policies

- Ability to work in fast-paced environment where multiple projects are in process and must be completed in a timely manner

- Advanced computer skills in Microsoft Office(Word, Excel, Outlook, etc.)

- Excellent written and verbal communication skills

- Versatility, flexibility, and willingness to work within constantly changing priorities

- Ability to deal effectively with a diversity of individuals at all organizational levels

- Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information presented through spoken words and sentences.

Supervisory Responsibility

- This position has no supervisory responsibilities

Supervision Received

- Infrequent supervision and instructions

- Infrequently exercises discretionary authority

Working Environment

- Primarily office

- Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets

- This position will occasionally require working in a laboratory setting, while following relevant safety protocols

Physical Demands

- Ability to work in an upright and/or stationary position for more than 8 hours per day

- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate office equipment

- Frequent mobility required

- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck

- Light to moderate lifting and carrying (or otherwise moves) objects including files and laptop computer with a maximum lift of 20 pounds

- Ability to access and use a variety of computer software

- Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken words and sentences

- Frequently interacts with others to obtain or relate information to diverse groups

- Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals; requires multiple periods of intense concentration

- Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence

- Ability to perform under stress and multi-task

- Regular and consistent attendance

Position Type and Expected Hours of Work

- This is a full-time position

- Some flexibility in hours is allowed, but the employee must be available during the “core” work hours as published in the BioAgilytix Employee Handbook

- Occasional weekend, holiday, and evening work required

- Occasional travel required

BENEFITS AND OTHER PERKS

Medical Insurance (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account (medical; dependent care), Short Term Disability | Long Term Disability Life Insurance, Paid Time Off (4 weeks per year), Parental Leave, Paid Holidays (12 scheduled; 3 floating), 401k with Employer Match, Employee Referral Program

COMMITMENT TO EQUAL OPPORTUNITY

BioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.

Quality Engineer I

BioAgilytix

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