Quality Assurance Technical Operations Specialist

Bachem; Vista (CA); Vor Ort; USD 98.000 - 135.000; Vollzeit

Benefits dieser Stelle

Annual performance bonus

Medical/Dental/Vision coverage

401(k) plan with employer contribution

Paid vacation, personal and sick days

Zusammenfassung

Bachem Americas is seeking a Quality Assurance Technical Operations Specialist in Vista, CA to enhance quality oversight, regulatory compliance, and internal procedures across API manufacturing processes.

The role focuses on evaluating quality systems, managing open quality events, and driving improvements with cross-functional teams. Requires 8+ years in a cGMP environment and deep QA experience.

Qualifikationen

• Bachelor's degree required for this role.
• Degree in Biological Sciences, Chemistry, or Engineering preferred.
• Minimum 8 years in a cGMP environment.
• Minimum 5 years in Quality Assurance.
• Experience in Pharmaceutical, Biopharmaceutical, or Medical Device industries preferred.
• Strong knowledge of cGMP investigations, including deviations and OOS.
• Proficient with CAPA, change management, and risk assessments.
• Experience with QA management systems (MasterControl, TrackWise, Veeva).

Aufgaben

• Evaluate global harmonization and local requirements to identify areas of improvement.
• Collaborate with Operations to drive corrective actions from quality events.
• Develop, maintain, analyze, and communicate Quality Event Metrics and KPIs.
• Develop and deliver focused training events for Operations personnel on cGMP compliance.
• Lead risk management initiatives across the site.
• Identify workflows to increase efficiency without compromising compliance.
• Maintain qualification for QA roles including document review and change management.
• Support client and health authority audits and inspections.

Kenntnisse

cGMP investigations

Root Cause Analysis

Technical writing

CAPA

Change management

Data analysis

Quality metrics

Collaboration

Training delivery

Problem solving

Interview techniques

Fishbone

5 Whys

Ausbildung

Bachelor's degree (required)

Bachelor's in Biological Sciences/Chemistry/Engineering preferred

Tools

MasterControl

TrackWise

Veeva

Jobbeschreibung

A Brief Overview

The Quality Assurance Technical Operations Specialist proactively enhances and improves the site's quality oversight, regulatory compliance, internal procedures, and quality standards in support of Active Pharmaceutical Ingredient (API) manufacturing processes. This role will identify and characterize opportunities for improvement within the Quality System, leveraging data, experience, and analysis to drive the collaborative improvement of processes and systems used by Quality Assurance, Quality Control, Manufacturing, Technical Operations, Process Development, Engineering, Validation, and Supply Chain teams. The position will be required to maintain qualification in all pertinent quality roles (review and approval of GMP documentation, change controls, deviations, investigations, CAPAs, risk assessments, and validation activities) to ensure a sound working knowledge of current processes, systems, strengths, and areas for improvement. As such, a small but consistent portion of this role's focus will be on the management of open quality events and document revision tasks, with a much broader focus on leveraging this working knowledge to drive improvements within the quality system.

A Brief Overview

The Quality Assurance Technical Operations Specialist proactively enhances and improves the site's quality oversight, regulatory compliance, internal procedures, and quality standards in support of Active Pharmaceutical Ingredient (API) manufacturing processes. This role will identify and characterize opportunities for improvement within the Quality System, leveraging data, experience, and analysis to drive the collaborative improvement of processes and systems used by Quality Assurance, Quality Control, Manufacturing, Technical Operations, Process Development, Engineering, Validation, and Supply Chain teams. The position will be required to maintain qualification in all pertinent quality roles (review and approval of GMP documentation, change controls, deviations, investigations, CAPAs, risk assessments, and validation activities) to ensure a sound working knowledge of current processes, systems, strengths, and areas for improvement. As such, a small but consistent portion of this role's focus will be on the management of open quality events and document revision tasks, with a much broader focus on leveraging this working knowledge to drive improvements within the quality system.

What You Will Do

• Evaluate global harmonization and local requirements to identify areas of improvement and increased efficiency, translating the evaluation into a highly collaborative revision or authoring of standard operating procedures and work instructions.
• Work collaboratively with stakeholders in Operations departments to drive meaningful and sustainable corrective actions stemming from quality events. Coach and assist, where necessary, to ensure that Corrective Actions are implemented completely and in a timely manner.
• Develop, maintain, analyze, and communicate Quality Event Metrics and KPIs, including Deviation, Change Management, Corrective Action, Risk Management, and Out-of-Specification.
• Develop, maintain, and deliver focused training events for Operations Personnel (QA, QC, Production, Fac/Eng) pertinent to cGMP Compliance and Quality Event workflows. Proactively identify coaching opportunities for Operations personnel regarding cGMP Compliance and Quality Events.
• Participate in and lead various risk management initiatives and activities, with a focus on driving proactive risk management and preventive action throughout the site.
• Identify workflows within Quality Assurance and other Operations departments that require enhanced efficiencies or simplification. Work collaboratively with key stakeholders of the workflows to make risk-based and controlled changes that increase efficiency without sacrificing cGMP compliance.
• Maintain qualification for all relevant job roles that support the Quality System, including Document review/approval, Deviation investigation/review/approval, Corrective Action, Change Management, Risk Management, and OOS review/approval.
• Support client and health authority requests, site visits, audits, and inspections as required.

Qualifications

• Bachelor's Degree required and
• Bachelor's Degree in Biological Sciences, Chemistry, or Engineering preferred
• At least 8 years in a cGMP environment required and
• At least 5 years working in Quality Assurance required and
• At least 5 years in the Pharmaceutical, Biopharmaceutical, or Medical Device industries preferred
• Strong applied knowledge of cGMP investigations, including deviations, out-of-specification, and environmental excursions.
• Strong applied knowledge of common Root Cause Analysis tools and techniques, including the use of proper interviewing technique, 6M Methodology (Fishbone), 5 Whys, Is / Is-Not.
• Strong Technical writing capabilities with direct application in report, investigation, Impact Assessment, and SOP writing.
• Proactive and a self-starter who is never averse to seeking help or guidance when required.
• Proficient with Corrective and Preventive Action (CAPA), including the establishment and measurement of effectiveness check.
• Proficient with Change Management governance, concepts, control points, and workflows.
• Excels with collaboration, drives trust and partnership with all stakeholder departments, and leverages experience with conflict resolution and teamwork to drive positive change within the organization.
• Experienced with data entry, sorting, analysis, and presentation in support of site Quality Metrics and Key Performance Indicators.
• Experienced with a variety of different industry Quality Management Systems (e.g. MasterControl, Trackwise, Veeva).

Base Annual Salary Range:

$97,972 - $134,712

Placement of new hires in this wage range is based on several factors including education, skill sets, experience, and training.

Total Rewards

We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.

Corporate Social Responsibility

Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem.

Bachem Americas is an Equal Opportunity Employer

As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status.

At Bachem, you’ll find a diverse, multicultural team. The (a) in the job title stands for all. We welcome applications from all candidates. What matters are your skills and motivation—regardless of age, gender, background, religion, or sexual orientation.