Manager – PM Credit Development
SouthState Bank
Quality Control Manager
BridgeBio
full-time
Posted on:
Location Type: Hybrid
Location: 🇺🇸 United States
Visit company websiteSalary
💰 $120,000 - $150,000 per year
Job Level
Mid-LevelSenior
About the role
- Review of analytical data for release, stability, and in-process testing at the contract manufacturing organizations in a timely manner
- Oversight of laboratories including investigations for out of specification, out of trend, deviations, and/or anomalous results
- Follow up with the contract laboratories to correct any deficiencies/omissions in the provided test packages
- Submitting test packages to QA for their review and loading all data into the electronic storage program
- Review of analytical data related to reference standard qualification, method validation and method transfer activities
- Travel, when necessary, to analytical testing sites or other sites
- Able to communicate results both internally and externally through oral and written updates and formal reports as necessary
- Create or review BBio Standard Operating Procedures as it pertains to Quality Control or management of contract analytical laboratories
Requirements
- M.S./B.S. in life sciences, ideally Chemistry, Analytical Chemistry preferred
- 5+ years’ experience in Quality Control in a pharmaceutical setting with solid knowledge of Good Manufacturing Practices (cGMP)
- 2+ years management experience
- Ability to communicate effectively with vendors regarding project scope, scientific results, and project updates
- Proven abilities in leadership and personnel management
- Strong oral and written communication skills
- Excellent organizational and planning skills and high attention to detail
- Demonstrated strong analytical skills, and the ability to work independently against multiple deadlines
- Sophisticated understanding how and when to appropriately apply the cGMP requirements; ability to distinguish regulated and non-regulated activities
Benefits
- Market leading compensation
- 401K with 100% employer match on first 3% & 50% on the next 2%
- Employee stock purchase program
- Pre-tax commuter benefits
- Referral program with $2,500 award for hired referrals
- Comprehensive health care with 100% premiums covered - no cost to you and dependents
- Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
- Hybrid work model - employees have the autonomy in where and how they do their work
- Unlimited flexible paid time off - take the time that you need
- Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
- Flex spending accounts & company-provided group term life & disability
- Subsidized lunch via Forkable on days worked from our office
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
analytical data reviewmethod validationmethod transferQuality ControlGood Manufacturing Practicesdata analysisstandard operating proceduresreference standard qualificationdeviation investigationout of specification testing
Soft skills
communication skillsleadershippersonnel managementorganizational skillsplanning skillsattention to detailindependent workability to meet deadlinesoral communicationwritten communication
