Jobs in the United States

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Added 1 min ago
Assistant Manager - Kitchen - #355
Sheetz, Inc
WALKERTOWN, NC
Looking for leadership experience? You’ll get it, with the chance to manage the entire food service program, including: inventory, preparation, promotion, production, service AND sales,…
Added 2 mins ago
EU
Technical PM
Experis USA
Greenwood Village, CO
- $58 to $66 USD / hour
…connectivity. The ideal candidate will have strong technical project leadership, excellent stakeholder communication, and the drive to remove roadblocks while delivering high-quality…
Added 2 mins ago
SF
2027 Summer Intern - SRO Process Analyst
State Farm
Bloomington, IL · Richardson, TX · Tempe, AZ · Dunwoody, GA
- $24 USD / hour
Excellent communication (written/verbal) and leadership skills to partner directly with business and/or operational stakeholders.
Added 2 mins ago
TO
Retail Supervisor
TJMaxx of IL, LLC
Bloomington, IL
- $16 to $16.5 USD / hour
…embraces diversity, fosters collaboration, and prioritizes your development. Whether you’re working in our four global Home Offices, Distribution Centers or Retail Stores - TJ Maxx,…
Added 2 mins ago
TO
Retail Supervisor
TJMaxx of IL, LLC
Bloomington, IL
- $16 to $16.5 USD / hour
…embraces diversity, fosters collaboration, and prioritizes your development. Whether you’re working in our four global Home Offices, Distribution Centers or Retail Stores - TJ Maxx,…
Added 2 mins ago
TT
Retail Backroom Coordinator
The TJX Companies Inc
Newnan, GA
- $14.25 to $14.75 USD / hour
…embraces diversity, fosters collaboration, and prioritizes your development. Whether you’re working in our four global Home Offices, Distribution Centers or Retail Stores - TJ Maxx,…
Added 2 mins ago
S
Director of Strategy and Capabilities
Sourcewell
Remote, United States
- $154,400 to $193,000 USD / year
Lead the development and implementation of strategy, anticipating complex issues, challenges, and opportunities and ensuring integration with wider functional strategy.
Added 2 mins ago
Customer Reliability Engineering Manager
Phaidra
Remote, United States
…work closely with the Customer Success Managers, Technical Program Managers, Solutions Engineers, Data Scientists, Account Executives and Product. Your goal is to help build the best…
Added 3 mins ago
Outpatient Clinical Specialty Pharmacist
Ascension
Murfreesboro, TN
Serving as a Consultant: Acting as a trusted advisor to medical staff and clinical leadership, providing real-time drug information and recommending formulary alternatives that prioritize…
Added 3 mins ago
Assistant Manager - Quality Assurance
Kellanova
Taloja, IN
Conduct daily GEMBA walks and regular program-effectiveness checks, using observations and data to strengthen standards and operational discipline.
Added 5 mins ago
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Sales Floor Supervisor - Mckinley Mall
Penney OpCo LLC
Blasdell, NY
- $23 to $28.75 USD / hour
Demonstrates Leadership: Creates an environment that fosters teamwork, recognizes others' accomplishments and respects and values differences in the workplace. Requires high personal and…
Added 6 mins ago
Registered Nurse – CT Workforce Student Day
Yale New Haven Health
New Haven, CT
Our team includes nurses with decades of experience alongside emerging clinicians building their expertise. All RNs are encouraged to advance through the SPIRE clinical advancement program.
Added 6 mins ago
Director, Prospect Management
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NEW HAVEN, CT
Provide strategic direction for the prospect research program, including innovative data development, information management, policy and process improvements and system enhancements with…
Added 9 mins ago
Program Coordinator 1 (PCN 07-5544)
State of Alaska
Seward, AK
As a Program Coordinator, you will serve as a subject matter expert responsible for all activities involved in the planning, implementation, administration, oversight, evaluation and…
Added 10 mins ago
Project/Program Operations Productivity Focal
Applied Materials
Boise, ID · Boise
Ensures that all phases of project, program and/or process development are documented and that information required in other functional areas is reported, disseminated, or transferred, as…
Added 10 mins ago
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UNAVAILABLE · Richland, WA · Seattle, WA · Portland, OR
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Post Doctorate Research Associate - Analytical Methods and Laboratory Automation
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Added 11 mins ago
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Hands-on leadership style with a passion for hospitality.
Added 11 mins ago
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Medical Director / Attending Physician
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- $250,000 to $300,000 USD / year
…best practices across the healthcare team. You will provide leadership, guidance, and direction to clinical staff, fostering a collaborative environment while maintaining the highest…
Added 11 mins ago
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6-month Architecture Internship (Winter 2027)
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Added 12 mins ago
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CSBio

Manager, GMP Quality Assurance

Milpitas, CA, United States

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Job details

Posting language: English
Posted: Nov 3, 2026

Original job description

CSBio is a peptide contract manufacturing founded in 1993. CSBio initial products were a complete line of automated synthesizers for manufacturing and process development, with a focus on cGMP production. In 1994, CSBio opened a custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies worldwide. In 2004, CSBio opened a peptide production facility in Menlo Park, CA and in 2014, CSBio expanded production capability through the addition of a new, state of the art building dedicated to cGMP peptide production. In 2017, CSBio passed a FDA inspection and were recommended to be approved for commercial drug substance manufacturing. In 2023, additional cGMP clinical production capacity was added in Milpitas, CA. CSBiois seeking a hands-on Quality Assurance Manager to supervise daily QA activities supporting peptide manufacturing, laboratory operations, materials, documentation, and cGMP compliance. This person will manage QA staff and directly support document review, deviations, CAPAs, change controls, training, batch-record review, audits, and inspection readiness. Core duties and responsibilities include the following:

Job Duties:

Supervise daily QA work, assign priorities, review completion, train staff, and provide practical guidance on cGMP documentation and quality-system requirements.
Review executed batch records, laboratory records, equipment and cleaning records, logbooks, labels, and supporting documentation for completeness and compliance.
Manage or support deviations, investigations, CAPAs, change controls, nonconformances, complaints, and effectiveness checks; ensure actions are documented and completed on time.
Coordinate document control, SOP issuance, periodic review, archival, forms, templates, and controlled-copy practices.
Support employee training assignments, completion tracking, qualification records, and documentation of GMP readiness.
Partner with Manufacturing, QC, Materials, Facilities, Validation, Regulatory, and management to resolve quality issues and prevent avoidable delays.
Provide QA review and approval of validation plans, risk assessments, protocols, reports, and qualification documentation for facilities, utilities, equipment, processes, cleaning, analytical methods, and software systems.
Work with system owners to maintain a practical validation assessment plan and address gaps in current or legacy validation documentation using documented risk-based decisions.
Support supplier qualification, material-status decisions, quality agreements, vendor documentation, and supplier corrective actions as assigned.
Manage or support customer-complaint investigations and approved recall or product-withdrawal procedures, including documentation, reconciliation, and authorized notifications.
Conduct or coordinate internal audits, floor observations, documentation reviews, and follow-up of findings.
Prepare QA records and subject-matter experts for customer audits and regulatory inspections; track requests, responses, observations, and commitments.
Monitor practical QA metrics such as overdue investigations, CAPAs, change controls, document reviews, training, batch-record review, and recurring documentation errors.
Escalate product-quality, patient-safety, data-integrity, compliance, and release risks promptly to authorized Quality leadership.
Improve QA workflows, templates, training, and quality-system usability without transferring QC laboratory or Manufacturing ownership into QA.

Requirements

Bachelor’s degree in life sciences, chemistry, engineering, pharmacy, or a related field, or equivalent relevant experience.
5+ years of Quality Assurance or closely related cGMP experience in pharmaceutical, biotechnology, peptide, API, sterile, medical-device, or other regulated manufacturing.
2+ years of supervisory, lead, or functional-management experience, including work assignment, training, review, and employee development.
Hands-on experience with deviations, CAPAs, change controls, document control, training, batch-record review, audits, and inspection readiness.
Working knowledge of cGMP documentation, data integrity, traceability, quality risk, and cross-functional escalation.
Working knowledge of applicable FDA and ICH expectations and risk-based validation practices.
Strong judgment, written communication, investigation, organization, and follow-through skills.

Benefits

Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 85% for Employee and 50% for Employee’s family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed)
Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental).
Disability insurance 50% standard employer paid.
401k 10% 1:1 match
PTO policy. 10 days PTO
Companywide paid holiday during: Week of July 4, Thanksgiving (2 days), Week of December 25
Carpool, clean air vehicle, and cell phone reimbursement
Employee rewards and recognition program
Company organized social events
Quarterly sponsored team building activities

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