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QA Manager In-Plant

Company: AGC Biologics
Location: Boulder
Posted on: January 15, 2022

Job Description:

AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com

Summary

The Manager, Quality Assurance position is responsible for the Management of the Quality Operations for Adjuvant Manufacturing and will be instrumental in the establishment of quality processes supporting this new manufacturing operation. We are looking for a passionate individual who can excel in a dynamic environment and who can provide leadership and technical mentorship to the Quality team.

Principal Responsibilities
Ensuring site Quality Operations policy and procedures are in place, are maintained current to corporate and regulatory requirements, and effectively meeting the needs of GMP Operations.
Proactively address GMP compliance concerns and resolve problems
Provide in plant QA support for Manufacturing adjuvant
Review and approve executed batch production records and product testing records
Work on complex problems that involve groups outside of QA as well as clients
Partners with other departments/groups for corrections and problem solving
Review and approve deviations and corrective actions
Review and approve site SOPs, master batch records and test methods related to adjuvant production
Review and approve test method and process validation documents
Participate in GMP-related problem resolution
Provides direct supervision to exempt employees and/or skilled nonexempt employees
Manages QA support for the review and approval batch records
Assigns daily/weekly tasks to staff
Use best practices in training development and coaching
Performance appraisals
Represent QA department in cross-functional teams
Participate in and facilitates teams supporting regulatory inspection readiness
Other duties as assigned

Knowledge, Skills & Abilities
Strong verbal and written communications skills
Excellent analytical and problem-solving skills
Ability to seamlessly manage a variety multiple project simultaneously
Outstanding customer service skills with the ability to work effectively with diverse groups at various levels within the company
Deeply well organized, flexible, and responsive
Good judgement with strong interpersonal relationship, team building, and collaboration skills
Willing and able to travel

Education/Experience
Bachelor's degree in chemistry or life sciences or equivalent experience.
5+ years of relevant experience in a pharmaceutical or FDA/GMP environment.
Experience with vaccine or adjuvant manufacturing preferred or cell based production and purification technologies.
Management experience.
Ability to understand and apply GMP regulations as they relate to manufacturing, test laboratory and facility operations.
Experience in review of test method validation, equipment qualification and process validation preferred.
Demonstrated ability to effectively manage staff and multiple tasks utilizing organization and prioritization skills, driven to meet timelines, results-oriented.

Compensation Range

$101,300 - $130,700

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances

Keywords: AGC Biologics, Boulder , QA Manager In-Plant, Executive , Boulder, Colorado

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