Manager Quality

Vache Marcarian Senior Manager

**********@***.*** https://www.linkedin.com/in/vache-marcarian-1283a189 818-***-**** Glendale, CA 91208

Driven manager with extensive experience in quality control and regulatory compliance. Analytical leader skilled in identifying areas for increased efficiency and cost savings. Collaborative team member with a history of success coordinating across departments to drive synergy and productivity. Proficient with c-GMP, cGTP, GLP, USP, EP, IRB, AABB and requirements for submissions of IND, BLA, and IMPD. Areas of Expertise include:

Process Improvement

Project Management

21 CFR 200 / 210

Stability Program

Regulatory Compliance

21 CFR 1271 / Part 11

Internal and External Audits

Microbiology

Pharmacovigilance/Safety

Quality Management Systems

Staff Training & Leadership

Clean room

Adverse Events

CAPA/nonconformances

ISO 9001 / ISO 13485

Supplier Quality

Complaints

Professional Experience

HEMACARE CORP. Van Nuys, CA 5/2016 – 6/2018

Regulatory Affairs / Quality Assurance Compliance Manager

Lead Continuous Improvement Program to increase operational productivity. Review and approve validation protocols and batch records. Cohost external audits including FDA, AABB, and OSHA, as well as customer audits. Conduct internal audits to ensure regulatory compliance with all relevant bodies. Act as Subject Matter Expert (SME) for HemaCare supplier/vendor quality program and oversee Quality Management Systems. Managing Customer Complaints and handling all SCARs.

Key Accomplishments:

Streamlined procedures, cutting redundant Track and Trend deviation by 50% year to year.

Incorporated various redundant QMS procedures resulting in 30% total reduction.

BAXALTA (BAXTER BIOSCIENCE) Westlake Village, CA 3/2009 – 5/2016

Quality Manager I, 12/2011 – 5/2016

Managed daily operations of Global Quality Safety Assessment (GQSA). Acted as point of contact for internal customers and maintained monthly and quarterly reports for management. Developed performance metrics for management reviews. Maintained Baxalta’s Adverse Event Reporting System (AERS) and workflow procedures.

Key Accomplishment:

Liaised with Global Pharmacovigilance on quality investigations and ensured 100% on-time completion rate.

Quality Associate III, 3/2009 – 12/2011

Supervised associate level staff across all day-to-day functions. Reviewed stability data for correctness and compliance with GMP/GLP requirements. Monitored ongoing studies for completion. Designed and managed Stability Protocols for commercial and clinical programs.

Key Accomplishment:

Offered critical contributions to project successfully increasing maximum product shipping temperatures from 2-8C to 2-40ºC, saving shipping costs.

XENCOR INC. Monrovia, CA 10/2007 – 2/2009

Product Testing Manager

Generated stability protocols and reported stability data for retest period extensions of DS/DP. Managed lot release, in-process samples plans, and CofA for lot release. Facilitated QC compliance meetings with team members from AS, QA, PD, manufacturing, and Bioassay groups. Managed contract testing laboratories and Quality Audits.

Key Accomplishment:

Reduced costs of relabeling for EU by extending retest period of DS/DP through data extrapolation.

AMGEN INC. Thousand Oaks, CA 3/2003 – 10/2007

Manufacturing Specialist II, 8/2006 – 10/2007

Liaised with area managers to develop corrective and preventative actions utilizing Six Sigma problem solving. Coordinated across departments to maintain team alignment and operational efficiency.

Key Accomplishments:

Investigated and closed non-conformances and CAPAs as per global procedures with 100% on-time completion.

Monitored open NCs and ensured compliance with established timelines and closures with 100% success rate.

Product Stability Quality Specialist I, 3/2003 – 8/2006

Oversaw daily operations of associate staff. Designed and managed Stability Strategies and Protocols. Represented Stability Department in Product Quality Teams at early phases for commercial products. Issued technical reports. Acted as Site Stability Representative for Global Stability Program and Statistical Analysis Project.

Key Accomplishment:

Analyzed and extrapolated data to extend shelf life of clinical products and reduce relabeling costs for EU.

BAXALTA (BAXTER BIOSCIENCE) Los Angeles, CA 6/1996 – 2/2003

Product Scientist – Product Stability Department

Designed and managed Phase III and Commercial Stability Strategies. Planned and monitored new and existing product testing. Created protocols for stability studies and wrote stability reports. Communicated and worked with various departments including Technical Services, Quality Control, and R&D to ensure smooth productivity. Assisted hiring contractors for validation of test chamber.

Key Accomplishment:

Participated as key member in teleconferences with FDA resulting in abbreviated Annual Protocols, reducing test intervals by 50% with a template that was applied to all other commercial products.

Quality Control Analyst – In-Process Laboratory and Microbiology

Various Biochemistry analysis for in-process and final products. Environmental monitoring of cleanrooms for viable and nonviable particles.

Education & Training

Bachelor of Science in Medical Technology – Clinical Microbiology and Biochemistry

CALIFORNIA STATE UNIVERSITY Los Angeles, CA

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