Lead, Accountability Clerk

AVEVA DRUG DELIVERY SYSTEMS INC•Miramar, FL

5d•Onsite

About The Position

Reviews production batch records, writes and reviews work plans, monitors data for trends and updates metric databases accordingly. Performs clerical and administrative duties to support the department.

Requirements

Associates (A.A./A.S) or Bachelor’s (B.A./B.S) in Science, Business, or related discipline
A minimum of 5 years of relevant pharmaceutical experience in a fast-paced lean Manufacturing/Packaging organization in a GMP environment.
A minimum of 8 years of relevant pharmaceutical industry experience in a fast-paced lean Manufacturing/Packaging organization in a GMP environment will be considered for candidates with less than a Bachelor’s degree.
Ability to work within a diverse team environment (as part of a team) as demonstrated through previous work experience.
Ability to read English and interpret documents and batch records.
Ability to write and word process English.
Ability to speak English effectively and communicate with all company employees.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions and decimals.
Ability to round decimals, compute ratio, percent and interpret data graphically.
Must possess basic Microsoft excel, word and access software knowledge.
Demonstrated ability to handle multiple priorities in a fast paced environment.
Knowledge of FDA, cGMPs, and SOPs related to job requirements.

Nice To Haves

GMP documentation and batch record review experience would be an asset.
ERP systems knowledge with JDE experience would be an asset.

Responsibilities

Performs the production review of manufacturing and packaging batch records and work plans.
Reviews and monitors statuses of departmental process orders.
Tracks batch record and work plan documentation errors.
Initiates and/or reviews NOEs as needed.
Conducts training as needed.
Presents batch record error information to operators at monthly production meetings.
Acts as backup for writing the finishing work plans as needed.
Acts as backup for completing statistical process control workbooks as needed.
Acts as backup for data entry of on-line coat weights as needed.
Performs special projects and assignments as needed.
Works as a member of a team to achieve all outcomes; Performs all work in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements; Delivers all work in support of our corporate values: Innovate, Evolve and Excel.
Trains departmental employees on JDE transactions.
Creates JDE labels and Avery labels for commercial and developmental projects as needed.
Perform the monthly production metric for the Quality Council meetings.
Perform the monthly production project hours to Finance.
Review daily the MFG/PKG shift notes and confirm the hours in JD Edwards.
Validates SPC workbooks.
Executes the Production APR report section.
Acts as backup for MFG/PKG work order Full Completions and work order Release for Accounting in JD Edwards.
Track and update the Production Headcount and the Production DLM report.
Works closely with OpEx to assist with metric trending and executive level presentations.
All other relevant duties as assigned. Ex. PC652 Production report, Coat Weight data, PKG yields.
Performs miscellaneous duties as assigned by the Director, Sr. Director or Vice President of Production/Technical Operations.