Quality Assurance Manager
To see similar active jobs please follow this link: Remote Management jobs
Job Title:Quality Assurance Manager, Biopharma Remote (JP10410)
Location:Thousand Oaks, CA (Remote, able to support PST/EST)
Employment Type: Contract
Business Unit:GxP Computer Systems QA Process Support
Duration:6+ months with likely extensions
Posting Date:06/07/2022
3 Key Consulting is hiring aQuality Assurance Managerfor a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:
Remote position; EST and PST hours preferred.In support of clients Quality Assurance program manages and oversees the operations of a specific area(s) of responsibility
FUNCTIONS:
- Responsible for hiring, training, supervising and performance management of staff.
- May perform or oversee the following functions:
- Review and approve product MPs
- Approve process validation protocols and reports for Mfg. processes.
- Approve Environmental Characterization reports
- Approve planned incidents
- Represent QA on NPI team
- Lead investigations
- Lead plant audits, participate in site audits
- Approve change-over completion
- May perform work of QA Specialist
EDUCATION/LICENSES
Doctorate degreeorMasters degree and 3 years of directly related experienceor
Bachelors degree and 5 years of directly related experience.
Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources.
COMPETENCIES/SKILLS
- Project management skills
- Strong organizational skills, including ability to follow assignments through to completion.
- Initiate and lead cross functional teams.
- Collaborate and communicate with higher level outside resources.
- Skill and knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and process development.
- Strong communication (both written and oral), facilitation, and presentation skills.
- Strong skill in working independently and to effectively interact with various levels.
- Ability to lead and influence staff outside own organization.
- Ability to motivate staff and manage and distribute work loads.
- Able to manage performance issues and conflict
- Ability to provide direction and establish goals for individual staff members and work group.
- Ability to evaluate documentation/ operations according to company and regulatory guidelines
- Ability to interact with regulatory agencies
- Demonstrate the company Values/Leadership Practices
Preferred Qualification
Available to work in 2nd shift and non-standard shift.
Why is the Position Open?
Supplement additional workload on team.
Top Must-Have Skill Sets:
- Computerized System Periodic Review
- Validation experience
- Quality Record Management Experience (change control, deviations)
- Supplier evaluations/ assessments (activity)
- Strong writing skills/ concise communication
Day to Day Responsibilities:
Perform Computerized System Periodic Review, Validation, Quality Record Management (change control, deviations)
Supplier evaluations/ assessments (activity) periodic reviews
Red Flags:
- No quality assurance experience, no regulated industry experience.
- Candidate needs to be a self starter and seasoned in this industry (5+ years would be ideal) - Aerospace, Biotech, pharma highly preferred
- Candidate should have strong writing skills and be able to briefly but concisely explain a project.
Employee Value Proposition:
Unique opportunity, growth, experience
Interview process:
Phone screening followed by video interview.
We invite qualified candidates to sendyour resume torecruiting@3keyconsulting.com. Ifyou decide that youre not interested in pursuing this position, please feel free to take a look at the other positions on our websitewww.3keyconsulting.com/careers. You are welcome to also sharethis opportunity withanyone you think might be interested in applying for this role.
About the job
Quality Assurance Manager
To see similar active jobs please follow this link: Remote Management jobs
Job Title:Quality Assurance Manager, Biopharma Remote (JP10410)
Location:Thousand Oaks, CA (Remote, able to support PST/EST)
Employment Type: Contract
Business Unit:GxP Computer Systems QA Process Support
Duration:6+ months with likely extensions
Posting Date:06/07/2022
3 Key Consulting is hiring aQuality Assurance Managerfor a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:
Remote position; EST and PST hours preferred.In support of clients Quality Assurance program manages and oversees the operations of a specific area(s) of responsibility
FUNCTIONS:
- Responsible for hiring, training, supervising and performance management of staff.
- May perform or oversee the following functions:
- Review and approve product MPs
- Approve process validation protocols and reports for Mfg. processes.
- Approve Environmental Characterization reports
- Approve planned incidents
- Represent QA on NPI team
- Lead investigations
- Lead plant audits, participate in site audits
- Approve change-over completion
- May perform work of QA Specialist
EDUCATION/LICENSES
Doctorate degreeorMasters degree and 3 years of directly related experienceor
Bachelors degree and 5 years of directly related experience.
Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources.
COMPETENCIES/SKILLS
- Project management skills
- Strong organizational skills, including ability to follow assignments through to completion.
- Initiate and lead cross functional teams.
- Collaborate and communicate with higher level outside resources.
- Skill and knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and process development.
- Strong communication (both written and oral), facilitation, and presentation skills.
- Strong skill in working independently and to effectively interact with various levels.
- Ability to lead and influence staff outside own organization.
- Ability to motivate staff and manage and distribute work loads.
- Able to manage performance issues and conflict
- Ability to provide direction and establish goals for individual staff members and work group.
- Ability to evaluate documentation/ operations according to company and regulatory guidelines
- Ability to interact with regulatory agencies
- Demonstrate the company Values/Leadership Practices
Preferred Qualification
Available to work in 2nd shift and non-standard shift.
Why is the Position Open?
Supplement additional workload on team.
Top Must-Have Skill Sets:
- Computerized System Periodic Review
- Validation experience
- Quality Record Management Experience (change control, deviations)
- Supplier evaluations/ assessments (activity)
- Strong writing skills/ concise communication
Day to Day Responsibilities:
Perform Computerized System Periodic Review, Validation, Quality Record Management (change control, deviations)
Supplier evaluations/ assessments (activity) periodic reviews
Red Flags:
- No quality assurance experience, no regulated industry experience.
- Candidate needs to be a self starter and seasoned in this industry (5+ years would be ideal) - Aerospace, Biotech, pharma highly preferred
- Candidate should have strong writing skills and be able to briefly but concisely explain a project.
Employee Value Proposition:
Unique opportunity, growth, experience
Interview process:
Phone screening followed by video interview.
We invite qualified candidates to sendyour resume torecruiting@3keyconsulting.com. Ifyou decide that youre not interested in pursuing this position, please feel free to take a look at the other positions on our websitewww.3keyconsulting.com/careers. You are welcome to also sharethis opportunity withanyone you think might be interested in applying for this role.