Quality Assurance Technical Operations Specialist

Bachem Holding AG; Vista (CA); On-site; USD 98,000 - 135,000; Full time

Benefits offered by this job

Medical/Dental/Vision coverage

401(k) plan with employer contribution

Paid vacation, personal and sick days

Job summary

Bachem Americas is seeking a Quality Assurance Technical Operations Specialist to strengthen quality oversight across API manufacturing. You will collaborate with QA, QC, Manufacturing, Process Development, Engineering, Validation, and Supply Chain to drive improvements in quality systems and procedures.

You will manage quality events, deviations, CAPAs, change controls, and risk assessments while maintaining qualifications in key QA roles. Strong writing and training skills are essential.

Qualifications

• Bachelor's Degree required; biological sciences, chemistry, or engineering preferred.
• At least 8 years in a cGMP environment.
• At least 5 years in Quality Assurance.
• Experience in the Pharmaceutical, Biopharmaceutical, or Medical Device industries preferred.
• Strong cGMP investigations knowledge (deviations, OOS, environmental excursions).
• Proficient with CAPA, change management, risk management.
• Strong technical writing capabilities.
• Proactive, self-starter with willingness to seek guidance when required.
• Collaborates across QA, QC, Manufacturing, Engineering, and Supply Chain.

Responsibilities

• Evaluate global harmonization and local requirements and rewrite SOPs and work instructions.
• Drive corrective actions from quality events with coaching to ensure timely completion.
• Develop and communicate Quality Event Metrics and KPIs (Deviation, Change, CAPA, Risk).
• Develop and deliver focused trainings for Operations personnel on cGMP compliance.
• Lead risk management initiatives to drive preventive actions site-wide.
• Identify workflows to improve efficiency while maintaining cGMP compliance.
• Support client and health authority requests, site visits, audits, and inspections.

Skills

cGMP knowledge

Root Cause Analysis

Technical writing

CAPA

Change Management

Data analysis

Cross-functional collaboration

Training

Audit support

Quality Metrics

Education

Bachelor's Degree in Biological Sciences, Chemistry, or Engineering

Bachelor's Degree in a related field

Tools

MasterControl

Trackwise

Veeva

Job description

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.