Quality Assurance Control

Saveera D. Lalljee

*** ******** ****** • Bloomfield, NJ 07003 • 973-***-**** *******.*******@*****.***

OBJECTIVE

To obtain a challenging position as a Quality Assurance Specialist in the Pharmaceutical/Biotech industry to utilize my education and practical experience in the field of Pharmaceutical Chemistry.

EDUCATION

May 2003, Bloomfield College, Bloomfield N.J.

B.S., Chemistry (biochemistry concentration)

PROFESSIONAL EXPERIENCE

Dendreon Corporation, Morris Plains, NJ

Quality Assurance Associate , September 2010-Present

• Provide oversight for investigations of deviations to manufacturing process (Blood/Tablets/Capsules).

• Perform Batch Record preparation, issuance, and Batch Record review.

• Issue Controlled Labels and Forms.

• Perform Batch Record closure and Product Disposition.

• Review and approve GMP Controlled Documents including SOPs, Batch Records, and Test Methods.

• Ensure full GMP compliance for the disposition of Raw Materials and Components.

• Trained new QA Associates.

• Assist with initiation and closure of deviations and CAPA.

• Represent department in cross-functional teams, projects and GXP-related problem resolution.

• Participate in internal audits and regulatory inspections.

• Investigate and compile data for reviewed customer/product complaints

Celgene Corporation, Summit, NJ

Quality Control Data Reviewer, January 2007- December 2009

• Write review investigations/deviations as relates to laboratory failure/OOS, deviations from method, and human error etc.

• Ensure compliance of cGMP documentation to internal SOP’s, test methods, material specifications, and regulatory requirements.

• Review analytical testing data to support clinical and commercial release and stability

• Support laboratory investigations

• Worked closely with analysts to improve the consistency and reliability of chromatographic peak integration in the group, as well as trained various analysts on good documentation practices.

• Set up data base tracking system for analyst documentation errors and review times

• Primary contact for data review of contract laboratories

• Trained multiple analysts to act as data reviewers

• Assisted in the development of the new data reviewer qualification SOP

• Coordinated the data review activities across groups to reduce the turn-around time from ~20 days to ~5 days.

Quality Control Analyst, August 2003- December 2006

• Provided analytical training to both internal and external personnel.

• Schedule method transfer activities to optimize efficiency and meet tight project timelines.

• Analyzed stability and release pharmaceutical products using established test methods for assay, content uniformity, purity, dissolution, Optical Rotation, and FT-IR testing, with little or no supervision within the timeframe specified.

• Trained analyst in analytical instrumentation and methodology (HPLC, FTIR, UV, Optical rotation, etc).

• Recorded, evaluated, and reviewed data for acceptability and conformity to specifications, as per site-specified analytical procedures, SOP’s and cGMP’s.

• Maintain productivity for quality and quantity.

• Supported Method Development and Method Validation activities.

• Performed troubleshooting of instrumentation and methods.

• Performed reference standard qualification testing

• FDA interaction

Instrumentation and Equipment

• HPLC: Agilent 1100, Waters Alliance, Shimadzu

• IR

• KF

• UV Spectrophotometer

• Wet Chemistry (titrations, heavy metals, etc.)

• Dissolution Testing: dissolution with automatic liquid samplers, manual equipment

• Software: Millenium, Empower, Qumas, EduNeering, Chem-Station, LIMS, ELN, Oracle, Plateau, EQMS

• Computers: Windows, Microsoft Office (e.g. Excel, Word, PowerPoint, etc)

TRAINING

• Six years of cGMP pharmaceutical industry experience

• Millennium Training (Waters)

• Theory and Practice of HPLC (Advanza)

• HPLC Method Development (Advanza)

• Preventative Maintenance HPLC (Shimadzu)

• Secret of Successful Technical Writing (Rockhurst University)

• Business of Grammar for Busy Professionals, Working Words, AQL Acceptance Sampling Course.

REFERENCES

References furnished upon request.

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