What are the responsibilities and job description for the QA Batch Record Auditor (Tues-Sat) position at Perrigo?
Perrigo Company is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold. Help us do it.
External applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you.
Description Overview
Please note the shift for this position is Tuesday-Saturday, 8:00 am-4:30 pm.
The Batch Record Auditor will be responsible for auditing batch records and resolving non-routine exceptions and accompanying paperwork to assure that raw material and finished product batches were produced in compliance with cGMP’s and to assure that the product meets current acceptable specifications.
Scope of the Role
- Audits internal and 3rd party batch records to ensure that batches are manufactured and/or packaged according to approved SOP’s. Assure that specified sampling and testing is complete, acceptable, and accounted for prior to batch disposition, and that cGMP errors are resolved, and quality incident investigations closed out.
- Review raw material records to ensure specifications and testing requirements are met.
- Works extensively in SAP by restricting, rejected, releasing, segregating and verifying accuracy of inventory.
- Work closely with internal, as well as sub-contract manufacturing Production, Packaging, QC and QA personnel to address production and testing concerns.
- Follow cGMP’s, SOP’s and Work Instructions.
- Logging finished product for testing and ensuring appropriate tests are assigned.
- Assist with manufacturing deviation investigations. Other duties as assigned.
A successful candidate will have:
- Ability to work independently and/or with minimum supervision against multiple deadlines.
- Excellent oral and written communication skills, and strong interpersonal skills.
- Strong attention to detail.
- Strong analytical skills.
- Able to work and build relationships across functional departments.
- Excellent multi-tasking skills and flexibility to handle changing priorities.
Experience Required
- High school diploma or GED, advanced education strongly preferred.
- Minimum of 1 year experience in quality and operations.
- Minimum of 3 years' experience working in FDA regulated industry.
- Microsoft Office experience.
Preferred Experience
- Possess an understanding of and ability to apply cGMP’s. Must be able to recognize variances from cGMP’s.
- Thorough knowledge of SOPs and be able to provide clear direction and interpretation to staff in multiple areas.
- Thoroughly understand equipment operation and manufacturing/packaging processes.
- Demonstrates a thorough working understanding of the interactions of complex business and compliance practices and requirements.
- SAP experience strongly preferred
Position Physical Requirements
- Sitting frequently.
- Standing, walking, reaching, stooping, bending/stooping, pushing/pulling, and lifting up to 50 lbs. on an occasional basis.
- This would require the ability to, but not limited to, sit and type, lift files, open filing cabinets and bend or stand as necessary.
- Required to use hands and fingers to handle; feel or operate objects.
Perrigo Perks
Perrigo has a comprehensive benefits package. Including:
- Health, Vision, and Dental at reduced rates
- Quarterly and Annual Bonus
- Profit Sharing
- 401 (K) with Employer Matching
- Starting three (3) weeks of vacation
- Tuition & Gym Reimbursement
- And More!
External applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you.
We are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,’ veterans status’, military status’ and more are encouraged to apply. TOGETHER, we make lives better. #DIV
Salary : $46,600 - $58,900
