Quality Control Manager

Sahar Arefieg

**** ********** ****** ***********, ** 92683 714-***-****

abhnwl@r.postjobfree.com

PROFILE: QUALITY SUPERVISOR

Outstanding track record of introducing programs, policies, and procedures

that minimized errors, increased throughput, and improved quality control

(QC) efficiencies.

Career marked by 15 years of success planning, coordinating, and executing

quality operations to meet schedules, resolve quality issues, and exceed

expectations. Empowering leader skilled in developing, engaging, and

motivating peak levels of performance among quality professionals.

Recognized as resourceful QC Manager with consistent record of meeting

aggressive deadlines and ensuring timely speed to market.

SKILLS AND CAPABILITIES INCLUDE:

o Supervising activities of quality control staff in all aspects of

production, testing, and disposition quality. Hiring, training, and

managing performance of competent employees.

o Directing and implementing GMP programs for regulatory compliance,

leveraging in-depth knowledge of analytical, chemical, instrumental,

and automation disciplines.

o Planning, directing, coordinating, and prioritizing quality operations

activities to ensure production plans are met.

o Overseeing third party audit and customer complaint investigations,

resolving problems involving product inquiries and quality issues, and

leading operations to clean audit results.

o Utilizing instrumentation including HPLC, UPLC, ICP, ICP-MS, and GC.

CORE COMPETENCIES INCLUDE:

( Quality Control (QC) ( Project & Program Management ( Team

Building & Leadership

( Method / Process Validation & Qualification ( Continuous

Improvement Initiatives ( Laboratory Investigations

( Regulatory, Labeling & Safety Compliance ( Quality, Cost & Delivery

Improvements ( Resource Allocation

( Laboratory Testing Planning & Scheduling ( Corrective & Preventative

Actions (CAPA) ( FDA/GMP/GLP/USP-DSVP

( Pharmaceutical/Nutraceutical ( Vendor Qualification & Procurement (

Change Control

( Cross-functional Team Collaboration ( SOP & QP (

Specifications/Formulations

( QC Lab Compliance Checks ( Problem Solving & Decision Making ( QC

Staff Mentoring

Professional Experience

NBTY Acquisition, LLC / Leiner Health Products, LLC - Garden Grove, CA

February 2007 - October 2014

Quality Control Manager

Managed quality control laboratory operations, encompassing analytical and

microbial labs. Provided oversight and direction for processes, resource

allocation, training, testing, and documentation. Coordinated and

prioritized testing for on-time turnarounds. Reviewed and approved

specifications and certificate of analysis (CofA). Conducted/participated

in method and cleaning validation/qualification studies, method transfer,

and hazard analysis and critical control points (HACCP) program. Reviewed,

evaluated, and approved qualification/validation protocols, data, and

reports.

Ensured and verified all laboratory operations complied with regulatory,

customer, product labeling, and safety requirements. Managed continuous

improvement projects for quality, cost, efficiency, and safety

improvements. Liaised between lab, internal teams, external customers, and

vendors worldwide. Resolved technical issues with customers, contract

vendors, raw material suppliers, and internal teams. Hired, trained,

developed, led, and managed performance of up to 38 direct reports.

o Improved sample throughput 45%, while reducing laboratory errors 25%

by introducing sample management program to process up to 1,200 lots

of raw materials, in-process samples, bulk, and finished products

monthly.

o Boosted bulk samples throughput 50%+ in less than four months by

spearheading process improvement project to improve global bulk

sampling and product disposition.

o Verified 150+ raw material specifications for high profile customer

more than 67% ahead of schedule, resulting in optimal compliance

levels and customer satisfaction.

o Spearheaded initiative to create consistent standard operating

procedures (SOPs) and quality/test procedures (QPs) for more than

1,000 procedures across eight different North America facilities and

one China-based facility in less than six months.

o Consolidated 347+ TLC procedures into one policy within one month,

saving company money and time.

o Played key role in improving sister lab's sample turnaround time 60%+

in four months as active participant in Kaizen event.

o Maximized efficiency and productivity, while eliminating overtime

during period of peak volume at ~1,200 lots per month by coordinating

and facilitating cross-training program for QC personnel.

o Eliminated rejections, reduced costs, and improved turnaround time by

actively participating in initiation and implementation of new global

program and conducting laboratory testing at source for raw materials

from selected vendor.

o Contributed to maximizing laboratories' compliance with ISO 17025 by

initiating implementation of several SOPs, policies, and best

practices.

o Reversed findings of several third party laboratory investigations and

resolved customer/consumer complaints by facilitating proactive and

comprehensive technical discussions with all stakeholders.

o Delivered substantial cost savings, while minimizing

failures/rejections by collaborating with internal/external customers

and vendors to evaluate discrepancies between customer formulations,

requirements and specifications, determine root causes, and provide

solutions for timely resolution.

o Aligned laboratory operations with volume fluctuations and business

needs by evaluating/reallocating resources and executing plan to

deliver significant cost savings.

o Led laboratory to consistently achieve finding-free audits by

optimizing best practices, ensuring compliance, and raising standards

for QC laboratory and staff. Led internal investigations, implemented

corrective/preventative actions, and investigated complaints in

preparation for external audit teams.

o Enabled production department to gain maximum flexibility and balance

network through on-time transfer of Top 100 bulks between NBTY

facilities by coordinating and leading successful on / ahead of

schedule completion of qualification studies.

Leiner Health Products, LLC - Garden Grove, CA January 1999 - February

2007

Quality Control Supervisor

Planned and scheduled QC testing of raw materials, in-process samples,

finished products, stability samples, and various special samples through

final disposition. Reviewed and approved specifications and certificate of

analysis (CofA). Coordinated and conducted internal / vendor method

validation and process qualification testing. Collaborated with

internal/external departments and stakeholders. Led and facilitated method

validation/verification and cross-training programs. Built and led team of

up to 38 direct reports.

o Recognized with customer achievement awards for reviewing, assessing,

and qualifying methods and specifications of China-based manufacturer

and U.S.-based customers.

o Enabled client to meet production schedules by qualifying products,

processes, and releases.

o Built reputation consistently meeting / exceeding targets and

deadlines for product and customer qualification, as well as speed to

market timelines.

o Delivered ~55% efficiency improvement over six-month period by

implementing 5S tools in QC laboratory.

Leiner Health Products, LLC - Garden Grove, CA July 1998 - January 1999

Lead Chemist

Promoted through ranks from initial hire as Chemist to coordinate,

prioritize, and review testing of raw materials, in-process samples,

finished bulks, contract manufactured samples, purchased bulks, and special

samples. Reviewed and approved specifications and certificate of analysis

(CofA). Participated in method validation/verification studies.

Education

Manhattan College - Bachelor of Science in Chemistry

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