Quality Assurance

SUMMARY OF QUALIFICATIONS:

Quality Assurance and Operational Professional with more than twenty-five years of significant, diversified experience in the organization, execution, and direction of procedures to assure quality of products and processes. Emphasizing maintenance of critical quality standards associated with packaging of pharmaceutical products. Achieved the title of Tech 1 to run packaging lines for manufacturing. Significant experience in packaging, reworking products for over 15 different products and/or put ups. Promoted to QA Auditor on 1st/3rd shift. Solely responsible for all my QA Department needs and issues for, at times, up to 12 different product lines. Issuing folders, approving mats, labels, and performing all line audits for any deviations. Have worked shifts 1, 2, and 3 to cover department needs. Attended and received certificate in GMP/Compliance and FDA requirements in pharmaceutical products at Raritan Valley Community College. A highly productive staff/team member and facilitator with diversified technical, analytical, and project leadership skills, the ability to communicate fluently and effectively in English, a strong commitment to achieve objectives as established, attention to detail, a resolute customer focus, and the capacity to utilize and integrate diverse resources in the timely processing of work flow and completion of projects.

Employment Capabilities:

Background highlighted by experience, training, and/or achievement in the following areas:

Quality Control

Considerable experience in planning and conducting programs to ensure continuous processing of products consistent with standards of quality, and maintaining job accountability in consistently meeting or exceeding established standards.

Solely responsible for all QA decisions/ audits on 3rd shift for up to, at times, 12 different product lines…

Studied specifications of products and processes to identify relevant standards of quality and

safety …

Conducted inspections and line audits to assure conformance to product standards, employing visual inspection and microscopy skills in performing functions including pre-production line clearances and intermediate and finished article evaluations to identify defects in diverse products and packaging …

Tracked and reported data regarding non-conformity with specifications, preparing and submitting a broad range of quality assurance and related documents including NCR’s, OSI Forms, Audit Forms, and Test Failure Reports …

Issued label approvals within an environment requiring strict adherence to FDA and other regulatory requirements …In charge of collecting Control Substance (Concerta) for DEA inspection.

Conducted and participated in meetings with quality, audit, manufacturing, and management personnel to secure feedback and build consensus for various quality initiatives …

Identified and resolved quality problems and established a consistent record in improving quality levels and reducing costs due to returns and reject accumulation …

Operational Leadership

Significant background in organizing and supervising operations and personnel within manufacturing and quality control environments, applying effective planning, coordination, facilitation, training, and leadership skills.

Analyzed and organized projects and functions, assuring adherence to performance standards …

Prepared schedules and established priorities for timely processing of work flow and completion of projects …

Identified and addressed environmental and safety risks, instituting modifications and other initiatives effective in their mitigation …

Applied computer literacy and knowledge of SAP, LIMS, and OneSource systems and other software applications in researching and tracking data and producing and reviewing batch records, forms, reports, and other documentation …

Conducted diversified skills, procedural, and safety training programs …

Delegated responsibilities, supervised, motivated, and evaluated performance of staff personnel …

Packaging Operations

Diversified experience in the set up, operation, and troubleshooting equipment and systems employed in the packaging of pharmaceutical products.

Achieved title as Tech 1 for running packaging lines…

Reviewed and interpreted processing schedules to determine packaging requirements …

Created and initiated manufacturing orders in computerized information management systems, ordering materials from vendors, assigning batch numbers to bulk products, and applying knowledge of AMAPS inventory control, DCS component coding, and CAPE palletization and casing systems …

Secured release of packaging components and fill materials from storage areas, maintaining all necessary records …

Initiated loading of materials and operation of machinery to begin line-processing sequence, ensuring compliance of operations with all GMP’s, SOP’s, and OMS’s …

Operated machinery to produce labels for finished goods …

Coordinated transfer of packaged/finished product from processing areas to storage and/or shipping areas for ultimate distribution …

Reconciled batches and prepared and presented daily reports to management regarding production output and issues …

oHEAD CERTIFIED TRAINER ( for all 3 shifts ) on line operations, packaging, reworking products, as well as, QA inspections.

EXPERIENCE: Roche (Packaging Operator 01/2016-03/2016

Zeus Industrials (Mfg Operator/ QC Inspector )Branchburg,NJ 2015 to 2016

Private Home( Healthcare Provider and Nanny ), for three clients in S. Carolina 2012 to 2014 Becton,Dickinson & Co- ( Hypodermic & Pen Needle Inspector)Sumter, S Carolina 2010 to 2012

Ortho-McNeil Pharmaceuticals GPSG – (Div. of Johnson & Johnson), Raritan, New Jersey 1985 to 2010

Quality Assurance Auditor (2003 to 2010)

Packaging Operator/Technician I (1985 to 2003)

G.P. Technologies, Somerville, New Jersey 1983 to 1985

Assistant Supervisor of Manufacturing & Quality Assurance (1984 to 1985)

Quality Control Inspector/Shipping Coordinator (1983 to 1984)

Baker & Taylor, ( Returns/Orderpicker/Shipping Clerk ) Somerville, New Jersey 1980 to 1983

EDUCATION:

Bridgewater-Raritan High School, Bridgewater, New Jersey

High School Diploma,

Raritan Valley Community College, Branchburg, New Jersey

Certified in GMP/COMPLIANCE and REQUIREMENTS in PHARMACEUITCAL PRODUCTS

Certified in AUTOMATED MANUFACTURING TECHNOLOGY.

REFERENCES AVAILABLE UPON REQUEST.

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