Quality Assurance Specialist

Staff Management Group is seeking a Quality Assurance Specialist for our client in Randolph NJ. Please read the ENTIRE job description and ALL of the job requirements BEFORE applying for this position.

Schedule:

• 1st Shift: 7:30AM - 4PM
• Plus Overtime

Pay Rate:

• $25 / hour

Job Summary:

The Quality Assurance Specialist will work with the Quality Warehouse and Production teams to ensure compliance with requirements of 21CFR Part 211 section 211.22 (a) (c). Work with all supervision and employees to ensure that cGMPs and SOPs policies and work instructions are being followed. Maintain policies and quality standards on the production floor and in the warehouse.

Job Responsibilities:

• Perform Acceptance Quality Level (AQL) sampling and evaluation as required to assure product quality
• Assist in ensuring Production Warehouse and all other facility areas are maintained in a state of compliance and control.
• Manages Monthly verification of AQLs and non-conformances.
• Partners with operations on any non-conformances as they occur.
• Ensures safety quality GMP GDP HACCP and housekeeping standards are adhered to.
• Assure all product/component packaging storage/preservation traceability and shipping policies are adhered to within the warehouse to ensure compliance with order/customer requirements to warehouse personnel.
• Conducts process audits throughout the facility to ensure compliance.
• Supports the Quality department with non-conformances as advised by the Quality Operations Manager.
• Review assessment and approval of non-conformance reports deviations OOS investigation environmental investigations audit reports Corrective/Preventative action requests consumer/customer complaints and material incidents.
• Ability to develop and update efficient documentation of work procedures (Standard Operating Procedures Work Instructions Forms Job Aids Templates).
• Supports management with an incident and/or deviation by investigating documenting and escalating issues as appropriate to the team.
• Ability to demonstrate strategic and critical thinking capability with strong project management skills focus on decision execution while balancing conflicting priorities.
• Provides timely notifications to the customer/supplier for incoming quality related issues as needed.
• Tracks and trends metrics for key quality performance indicators for cross-functional visibility
• Performs incoming/in-process Quality inspections statistical sampling and batch record review/release.
• Supports all Packaging operations cradle to grave.
• Serves as mentor/trainer to new Quality members and operational personnel as needed.
• Provides in-depth knowledge of governing regulations of packaging labeling serialization etc. of pharmaceutical medical devices food and combination products.
• Assists with Orientation and GDP/Data Integrity training.
• Works to improve the effectiveness of the quality management system through the use of the quality policy quality objectives audit results analysis of data corrective and preventive actions.
• Instills a sense of quality through modeled quality behaviors and mindset.
• Adherence to all Company policies procedures cGMPs and regulatory requirements.
• Flexibly works other shifts shifts maybe 8 10 or 12 hours as needed.
• Performs any other functions and duties assigned as necessary for the smooth and efficient operation.

Knowledge & Experience:

• Associates degree or equivalent combination required.
• Bachelors Degree or equivalent combination preferred.
• 3 years of GDP/GMP experience required.
• In-depth knowledge of governing regulations of packaging labeling serialization of pharmaceutical medical devices food and combination products preferred.
• The ability to work independently without supervision required.
• Ability to organize priorities and workload required.
• Ability to work and communicate with cross-functional teams.
• Ability to demonstrate critical thinking.

Computer/Communication Skills:

• Working knowledge of MS Office programs: Word Excel and Outlook required.
• Ability to speak and write professionally to and with customers
• Ability to present training topics to small or medium sized groups
• Ability to speak read and write English in a manner that is sufficient for effective communication with supervisors employees and customers: to include reading and writing skills to understand and complete necessary customer paperwork required.

Physical Requirements and Work Environment:

• Regularly required to walk stand bend twist reach with hands and arms stoop kneel and crouch.
• Raise and lower an object from one level to another less than 30 lbs.
• Good (corrected) eyesight and hand/eye coordination.
• Normal office environment with little exposure to dust and weather conditions prevalent at the time (i.e. cold hot/humid).
• May also require visits to production area where employee may be exposed to moving mechanical parts dust and weather conditions prevalent at the time (cold hot/humid).

Additional Information:

Staff Management Group is an equal employment opportunity employer and all qualified applicants will receive consideration for employment without unlawful discrimination based on race color creed national origin sex age disability marital status sexual orientation or citizenship status.

About Staff Management Group: Staff Management Group has over 30 years of experience placing staffing candidates in distribution manufacturing production assembly and clerical positions. Staff Management Group is one of New Jerseys leading staffing and recruiting agencies specializing in light industrial and clerical staffing. Come join the team!

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