Senior Quality Systems Engineer/APQR Lead

Tris Pharma Inc•South Brunswick, NJ

2d•$100,000 - $145,000•Onsite

About The Position

Tris Pharma, Inc. is seeking a Senior Quality Systems Engineer/APQR Lead to support and assist the Quality Assurance function. The role combines product data evaluation under FDA 21 CFR 211.180(e) with technical engineering controls to help ensure commercial products consistently meet safety, identity, strength, quality, and purity standards. The incumbent leads statistical trending, data collection and aggregation, and the drafting of Annual Product Quality Reviews/Annual Product Reviews (APQRs/APRs) to monitor product and process stability and support data-driven continuous improvement across production processes in accordance with SOPs, cGMPs, FDA standards, and batch record specifications. The position is based in an office/laboratory environment in Monmouth Junction, New Jersey. It requires working with large manufacturing, packaging, laboratory, complaint, deviation, CAPA, change control, and stability datasets; applying statistical methods and quality risk management; and collaborating with QA, Production, Laboratory, Technical Services, and other subject matter experts. The role may support inspections and regulatory audits and may cross-train in other QA areas as needed. Travel is listed as 0%.

Requirements

Bachelor’s degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, or a related scientific discipline, and at least 5 years of relevant experience in quality systems, process validation, product quality review, or quality engineering in the pharmaceutical or biotechnology industry, with increasing technical responsibility; or an equivalent combination of education and relevant experience.
Deep understanding of FDA 21 CFR Parts 210/211, ICH Q8, ICH Q9, and ICH Q10.
Familiarity with laboratory testing equipment such as automated dissolution testers, HPLC, particle size analyzers, and viscometers/rheometers.
Ability to translate statistical observations into quality risk assessments and business recommendations using risk management tools and structured decision-making methodologies.
Proficiency with statistical analysis platforms such as Minitab, JMP, or SAS for process trending and control charting.
Demonstrated experience with statistical methods, including control charting, process capability and trend analysis, regression analysis, hypothesis testing, ANOVA, sampling plans, and statistical interpretation of manufacturing and laboratory data.
Foundational knowledge of Process Validation lifecycle stages 1, 2, and 3 (Continued Process Verification); experience developing, monitoring, and interpreting CPV data and process performance indicators.
ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA).
Proficiency with Microsoft Office.
Excellent verbal and written communication skills.
Ability to work independently and collaboratively in a fast-paced, matrixed environment with internal and external team members.
Analytical thinking, excellent problem-solving skills, and adaptability to changing priorities and deadlines.
Excellent planning, organization, and time-management skills, including the ability to support and prioritize the stability program.
Fluency in spoken and written English.
Ability to identify and distinguish colors.
Ability and willingness to work additional hours as required by business needs.
Ability to lift up to 30 pounds, use personal protective equipment, and stand for extended periods.

Nice To Haves

Experience with various dosage manufacturing, including oral solid or liquid dosage forms and delayed- or extended-release products.
Lean Six Sigma Green Belt or Black Belt certification.
Experience with data visualization and reporting tools such as Power BI, Tableau, JMP Live, Spotfire, or equivalent platforms.

Responsibilities

Maintain assigned Quality-related documentation in compliance with company quality policies, practices, SOPs, cGMPs, and records-management requirements.
Lead evaluation of annual product quality data to identify quality risks, process variability, adverse trends, and opportunities for improvement; use statistical methods and quality risk management to support decisions.
Coordinate with departments, functions, and subject matter experts to obtain and submit APQR/APR sub-reports accurately and on time.
Host APR risk assessment meetings, track attendance, and follow up on team recommendations.
Perform advanced trend analysis for intermediate, in-process, finished product, and stability batches; evaluate critical quality attributes and critical process parameters, verify process consistency, and address and report negative trends.
Analyze manufacturing, packaging, laboratory, complaints, deviations, CAPAs, change controls, and stability data to identify statistically significant trends, process shifts, and emerging quality risks, including deviation and rejection profiles, batch failures, yield losses, and out-of-specification laboratory findings.
Apply control charts, process capability analysis, regression analysis, Pareto analysis, trend modeling, and other statistical methods to evaluate process performance and product lifecycle health.
Evaluate the cumulative impact of deviations, CAPAs, change controls, complaints, stability trends, analytical changes, and validation activities on product quality throughout the product lifecycle.
Recommend revalidation and assess the need for process revalidation or changes to registered specifications based on APQR/APR data and conclusions.
Drive root cause investigations with QA Investigations, Production, Laboratory, and Technical Services teams using tools such as Fishbone, 5 Whys, and FMEA; address technical risks related to company dosage forms and intermediates.
Monitor process capability and calculate and analyze Cpk and Ppk indicators to assess process variability.
Participate in inspections as needed and support regulatory audits as the subject matter expert for APQRs, trending data, and process statistics.
Assist in other QA areas and cross-train across the department as needed; perform other APR tasks assigned by the supervisor or Quality Senior Management.