Sr. Analytical Quality Assurance Specialist

Sr. Analytical Quality Assurance Specialist

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.

• 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.

• Please note: unsolicited resumes from recruitment agencies will not be considered.