Sr. Analytical Quality Assurance Specialist

Bachem Americas, Inc.; Vista (CA); Presencial; USD 98.000 - 135.000; Jornada completa

Descripción de la vacante

Bachem Americas, Inc. seeks a Sr. Analytical Quality Assurance Specialist to serve as a technical liaison between Quality Control and Quality Assurance.

This role ensures cGMP compliance for QC data, lab results, and documentation through collaboration and continuous improvement of laboratory systems. The candidate will lead investigations, author SOPs, review methods, and oversee environmental monitoring, stability data, and CAPA.

Formación

• Bachelor's degree in life sciences or related field.
• 8+ years in a cGMP environment.
• 5+ years in Quality Assurance and/or Quality Control.
• 3+ years in Quality Control.
• 3+ years in the Pharmaceutical, Biopharmaceutical, or Medical Device industries.
• Strong knowledge of cGMP investigations (deviations, OOS, environmental excursions).
• Proficient with CAPA, including effectiveness checks.
• Experience interpreting microbiological data (bioburden, endotoxin, environmental monitoring).
• Familiar with Change Management governance and QA systems (MasterControl, Trackwise, Veeva).
• Proven problem-solving and collaboration skills.

Responsabilidades

• Support QC investigations (OOS/OOT/OOE, deviations) and drive corrective actions.
• Author, revise, and approve SOPs, work instructions, and test methods.
• Review method development/validation documents and associated data.
• Ensure environmental monitoring, bioburden, endotoxin, and microbial testing compliance.
• Review stability protocols and reports to meet cGMP requirements.
• Provide quality oversight for QC studies from design to approval.
• Conduct laboratory walkthroughs to ensure safety, data integrity, and compliance.
• Oversee Invalid Assay program and environmental monitoring trend reviews.
• Drive risk-based investigations and data analysis within QA functions.
• Support client audits and inspections as required.

Conocimientos

cGMP investigations

Root Cause Analysis

CAPA

data interpretation

Quality Metrics

QA/QC experience

collaboration

problem solving

bioburden/environmental monitoring

Quality Management Systems

Educación

Bachelor's degree in life sciences or related field

Herramientas

MasterControl

Trackwise

Veeva

Descripción del empleo

Bachem Americas, Inc.

Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see www.bachem.com.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.

A brief overview

The Sr. Analytical Quality Assurance Specialist is a technical liaison between the Quality Control and Quality Assurance departments. This role will provide direct support and cGMP compliance oversight for all Quality Control functions and activities.

The position will be required to verify the accuracy, integrity, and compliance of analytical data, laboratory test results, and Quality Control documentation. The role will be highly collaborative and solution-oriented, with an emphasis on partnering with Quality Control colleagues on the continuous improvement of Laboratory Systems.

What you will do

• Support QC-related investigations, including OOS/OOT/OOE, Deviations, and System Suitability failures. Ensure cGMP compliance with all investigational findings and write-ups, partnering with the QC team to translate root cause into meaningful and sustainable corrective action.
• Work collaboratively with the Quality Control department to author, revise, and approve standard operating procedures, work instructions, and standard test methods.
• Review and approve method development and method validation documents, data, and results. Oversight will include the review and approval of associated protocols and final reports (including supporting raw data).
• Work closely with the QC Microbiology functions to ensure environmental monitoring, growth promotion, bioburden, endotoxin, water testing, and microbial ID testing are performed in a timely manner, per procedure, and properly evaluated against established acceptance criteria.
• Review and approve stability protocols, ensuring study design meets client and cGMP requirements. Review and approve stability reports, including the review of reportable data packets, ensuring that the study intent has been met, acceptance criteria have been met, and that any exceptions (e.g. deviation or OOS results) are properly documented and addressed within the report.
• Provide quality oversight for QC studies, including study design, acceptance criteria, execution, reporting, and approval.
• Perform functional area walkthroughs of the laboratory space(s) to ensure proper housekeeping, audit readiness, safety, data integrity, sample/reagent/ reference standard integrity, and procedural compliance. Report findings to an authorized QC representative and work with the QC team to remediate any noted deficiencies.
• Ensure proper oversight of the Invalid Assay program.
• Review and approve Environmental Monitoring trend reports.
• Champion and drive a risk-based approach within investigation management, data analysis and oversight, document revision, and good laboratory practices.
• Assist with the development of metrics and/or KPIs, translating emerging trends into partnership with QC to identify areas of improvement from a systematic perspective.
• Support client and health authority requests, site visits, audits, and inspections as required.

Qualifications

• Bachelor's degree in life sciences or related field
• 8+ years in a cGMP environment
• 5+ years working in Quality Assurance and/or Quality Control
• 3+ years in Quality Control
• 3+ years in the Pharmaceutical, Biopharmaceutical, or Medical Device industries
• 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 and applied knowledge of common QC analytical methodologies, with an emphasis on HPLC, UHPLC, GC, Karl Fisher, and FTIR.
• Strong experience authoring or reviewing various technical QC documents and records, including Method Development, Method Transfer, Method Qualification, standard test methods, standard operating procedures, stability protocols/reports, chromatograms (raw data packages), scientific notebooks, and logbooks.
• 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.
• Experience reviewing and interpreting microbiological data, including bioburden, endotoxin, air viable, surface viable, microbial ID, colony morphology, B&F, and environmental monitoring risk assessment.
• 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).
• Proven problem-solving skills and experiences

Base Salary Range: $97,972 - $134,712

Placement of new hires in these wage ranges 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.

Equal employment opportunity, including veterans and individuals with disabilities.

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