Job Description
Job Title (Internal)	Lead Accountability Clerk
Job Profile/Level:
Line of Business (LOB) or Business Process Stream (BPS)
Department/Org Unit:	Production Operations
Reports Directly To:	Manager/Sr. Manager, Production Operations
Reports Indirectly To:
People Leader	Yes
Number of Direct Reports and Job Titles
Revision Date (Month / Day / Year)	07/11/25
Revision Number:
Job Location:
Travel Requirements	No

 

Job Summary:

 

Reviews production batch records, write and review work plans, monitor data for trends and update metric databases accordingly. Performs clerical and administrative duties to support the department.

 

Job 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

 

 

 

Job Requirements

 

• Education

• Associates (A.A./A.S) or Bachelor’s (B.A./B.S) in Science, Business, or related discipline

 

 

• Experience

• A.S. or B.S. degree – 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.
• GMP documentation and batch record review experience would be an asset.

 

 

 

• Knowledge, Skills and Abilities

• 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.
• ERP systems knowledge with JDE experience would be an asset.
• Knowledge of FDA, cGMPs, and SOPs related to job requirements.

 

 

 

 

Job Requirements

 

• Education

• Associates (A.A./A.S) or Bachelor’s (B.A./B.S) in Science, Business, or related discipline

 

 

• Experience

• A.S. or B.S. degree – 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.
• GMP documentation and batch record review experience would be an asset.