What are the responsibilities and job description for the Manufacturing Compliance Specialist I (2nd shift) position at SHARP STERILE MANUFACTURING LLC?
Position Summary
Investigate process deviations, propose and implement effective CAPA, perform on the floor batch record review and monitor and measure ongoing performance of Manufacturing quality systems.
Duties and Responsibilities
Determine accurate root cause
Drive investigations to successful resolution
Cultivate strong interdepartmental working relationships
Track CAPA/Deviation owners to ensure on time completion
Issue reports and track metrics of all open manufacturing deviations, investigations, excursions, and corrective and preventative actions (CAPA)
Keep various quality and efficiency metrics as directed by manufacturing management
Facilitate the accurate and timely completion of manufacturing review of executed batch records, ensure batch records are completed in accordance with company SOPs, cGMPs, and customer specifications
Assist in the correction of deficiencies found within the documentation reviewed
Facilitate sound discussions on training adequacy and CAPA effectiveness
Other duties as required by management
Regulatory Responsibilities
Conduct business in a responsible manner that complies with all state, OSHA and HIPAA regulations
Maintain a detailed and comprehensive understanding of FDA, EU and other regulatory agency requirements
Supervisory Responsibilities
N/A
Experience
Two (2) years of work experience in pharmaceutical, IVD or Medical Device based cGMP manufacturing operations owning/leading complex deviations utilizing various root cause analysis tools preferred
Experience with equipment calibration and investigation of out of tolerance (OOT) preferred
Prior batch record experience preferred
Specific education/degree may be considered in lieu of above timeframes
Education
Associates degree preferred
Knowledge, Skills & Ability
In-depth knowledge of FDA regulations and cGMP systems
Applied knowledge of quality by design, six-sigma, and operational excellence tools in creating efficient and high-quality processes and end products
Excellent oral and written communication skills
Strong technical writing ability
Familiarity with manufacturing batch records
Able to work independently with minimal supervision and direction
Proficiency with computer systems including MS Office (Outlook, Word and Excel)
Physical Requirements
Frequent standing and walking throughout the facility
Stretches of sitting and typing
Satisfactory audio-visual acuity
Salary : $25 - $33
If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution.
Compensation Planning
Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right.
Surveys & Data Sets
What is the career path for a Manufacturing Compliance Specialist I (2nd shift)?
Sign up to receive alerts about other jobs on the Manufacturing Compliance Specialist I (2nd shift) career path by checking the boxes next to the positions that interest you.
Position Summary The Formulation Supervisor is a working supervisor role responsible for all aspects of formulation activities to ensure achievement of the...more
Position Summary Perform visual inspection of the manufactured drug product through the packaging process including visual inspection in compliance with co...more
Position Summary The Quality Systems Director is responsible for developing, implementing, and maintaining a robust Quality Management System (QMS) to ensu...more
Position Summary The Purchasing Expediter is responsible for supporting materials planning, purchasing, and inventory management activities to ensure the t...more
Not the job you're looking for? Here are some other Manufacturing Compliance Specialist I (2nd shift) jobs in the Lee, MA area that may be a better fit.
We don't have any other Manufacturing Compliance Specialist I (2nd shift) jobs in the Lee, MA area right now.
About us Cavallero Plastics, Inc. is a small business family-owned business since 1964 that family has maintained the same core principles focused on deliv...more
Position Summary Perform visual inspection of the manufactured drug product through the packaging process including visual inspection in compliance with co...more
