Quality Analyst Resume

SUMMARY:

Results focused and detail oriented professional, wif solid and diverse experience in Biotech/Pharmaceutical industry. Equipped wif extensive biotechnology and research background complemented wif in - depth understanding of process analytical technology.
Proven ability to evaluate and approve proposed changes to products, processes and controlled documents to identify regulatory impact to marketed/existing products.
Detail - oriented individual who exemplifies professionalism, and an ability to manage multiple projects and tasks at any given moment. Highly reliable wif acnoledged reputation for integrity and versatility in adapting to new roles, tasks, applications, and environments.
Well-developed interpersonal skills coupled wif outstanding verbal and written communication skills, able to establish and maintain effective working relationships across cross-functional teams and diverse individuals at any levels.

PROFESSIONAL EXPERIENCE:

Confidential

Quality Analyst

Responsibilities:

Monitors and Analyzes on proactive basis, highly complex queue data to ensure of contract and internal SLA and project commitments, interfaces wif managers to resolve issues
Identifies, communicates, and escalates issues when necessary, develops and implements solutions to issues as appropriate.
Develops and provides reports to higher level management.
Assists in establishing and documenting a tailored strategic quality control plan for teh performance of quality control activities for projects and tasks.
Develops and maintains standardized quality control documentation for project and tasks to include quality metrics.
Determines level of product quality, reports findings and escalates unresolved issues to teh appropriate level.
Evaluates work products to assess quality and reports findings. Researches Alternative solutions to problemsdetermines proper approaches, and makes verbal and /or written recommendations to appropriate parties.
Gathers, uses and independently analyzes defect metrics data. communicates analysis findings to appropriate level verbally and through teh preparations of periodic written reports.
Participates in process improvements in support of quality control initiatives.
Provides guidance to project staff on appropriate measures to remediate performance that fails to meet SLA.

Confidential

QC Associate

Responsibilities:

Quality Control testing of Raw Material and finished vaccine products.
Review and approval of QC generated raw data and analytical results of commercial testing of products manufactured at company including teh associated raw materials.
Perform random inspection and participate in general internal audit activities for QC and manufacturing .
Review of documentation of products or API manufactured externally to ensure it meets criteria for cGMP documentation.
Support all activities to continuously maintain teh GMP status of teh QC Laboratory (5S lean laboratory) and to continuously follow teh rules of EHS for a safe work environment.
Plan commercial sampling and testing activities in teh laboratory.
Ensure sampling of raw and packaged materials in collaboration wif upstream and downstream manufacturing, Fill finish, and Warehouse supervisors.
Provide technical support in all investigations related to all types of issues in teh context of Bioassay and Biochemistry.
Document management workflow, Change Control workflow management, Deviation Investigation.

Confidential

Quality Associate

Responsibilities:

Cell Line Manipulation of adherent and suspension cells.
Performed Method validation and Method transfer .
Performed Routine and Random testing to support manaufacturing,Quality Control and Analytical Technology.

Confidential

Research Associate

Responsibilities:

Successfully performed bacteria and plasmid isolation.
Worked on a Research project that earned teh Laboratory a $1 million Grant form teh National Institute of Diabetes and Digestive and Kidney dieases to continue wif teh preclinical trials using animal models.