Quality Assurance Technical Operations Specialist

Bachem AG•Vista, CA

4d•$97,972 - $134,712•Onsite

About The Position

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, 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.

Requirements

Bachelor's Degree required
At least 8 years in a cGMP environment required
At least 5 years working in Quality Assurance required
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).

Nice To Haves

Bachelor's Degree in Biological Sciences, Chemistry, or Engineering preferred
At least 5 years in the Pharmaceutical, Biopharmaceutical, or Medical Device industries preferred

Responsibilities

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.