Quality Control Associate

Surmodics Services & Technologies

Job Location:

Horsham, PA - USA

Yearly Salary: USD 57000 - 62000

Posted on: 9 hours ago

Vacancies: 1 Vacancy

Job Summary

Annual Compensation Range: $57000-$62000

Surmodics Services & Technologies (SST) (formerly Biocoat)is committed to providing the best in developing manufacturing and applying coatings on medical devices.We are looking for aQuality Control Associate to be part of a positive team-oriented environment.

Responsibilities:
Responsibilities include but are not limited to:

Establish execute review evaluate and optimize laboratory procedures and policies
Perform record and report quality control inspections and testing
Troubleshoot and participate in resolution of administrative or technical problems
Review batch records and supporting documents for production activities and release of product
Initiate facilitate assist and review investigations and associated work for NCPs CAPAs ECOs and failures forlaboratory-related events
Assist with purchase use storage and management of laboratory inventory/supplies.
Investigate customer complaints
Coordinate Material Review Board (MRB) meetings and facilitate material and documentation dispositions as needed
Author and review quality procedures templates forms and reports
Communicate deficiencies safety and/or compliance issues
Compile data and report QMS metrics as required (e.g. special projects product study Management Review)
Support audit preparation and performance audit activities

Skills & Requirements:

Bachelors degree in chemistry biology biomedical engineering or similar Life Science field required
Experience in regulated manufacturing lab setting a plus
Prior experience with ISO 9001 or ISO 13485 and/or experience with QMS documentation and Good Document Practices highly desirable
Ability to report evaluate and interpret scientific data to be successful in this role
Excellent math skills to adequately perform and interpret calculations and test parameters needed
Analytical approach to problem solving; critical thinker; uses data to substantiate decision making
Excellent technical writing skills with great proficiency in spelling grammar formatting and completeness of documentation with extreme detail required
Proficiency with Microsoft Word Excel and Outlook; Prior experience with eQMS or ERP systems highly desired
Ability to complete assigned tasks in a timely manner with minimal day-to-day direction while meeting deadlines
Strong interpersonal and communication skills (verbal/written)
Ability to follow and adhere to all Safety guidelines and processes including wearing appropriate lab gowning and other PPE as required.

The conditions herein are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential job functions.

Work Environment:
Office environment with occasional manufacturing and warehouse area exposure. Physical requirements are those that could be reasonably anticipated given the job duties and work environment.Exposure to hazardous chemicals in certain areas of the office. Must wear required personal protective equipment while demonstrating safe working practices.

Physical Requirements
Physical Demands: Stooping turning bending squatting kneeling and the ability to lift up to 30 pounds; constant/repetitive standing; requires normal correctable vision and hearing and the ability to accurately discern color as necessary to perform job functions.This position requires regular and sustained laboratory time around chemicals which may be hazardous. All personnel are required to follow all safety and chemical handling processes as outlined in various SOPs and Biocoats Chemical Hygiene Plan.

This position works within a Class 7 cleanroom for periods of time. All personnel are required to follow Biocoats requirements for gowning and conduct while working within this environment.

What SST Offers:

Competitive salary eligible for a discretionary bonus
Benefits (medical with HSA component dental vision critical illness and accident insurance)
Life insurance short- and long-term disability paid by the company
Flexible Spending Accounts (FSAs)
401(k) plan with an immediate company match
Paid time off
Education Assistance Program
Rewards and Recognition Program
Parental Leave
Employee Assistance Program
Additional benefits such as the opportunity to leave early on Fridaysbusiness casual dress friendly work environment and fun company events.

SST is anis an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race religion color national origin gender gender identity sexual orientation age status as a protected veteran status as a qualified individual with disability or any other protected characteristic under law.

SST Human Resources leads recruitment and employment for SST. Unsolicited resumes sent to SST from recruiters do not constitute any type of relationship between the recruiter and SST and do not obligate SST to pay fees should we hire from those resumes. We ask those external recruiters and/or agencies not contact or present candidates directly to our hiring managers or employees.

Required Experience:

Senior IC

Annual Compensation Range: $57000-$62000Surmodics Services & Technologies (SST) (formerly Biocoat)is committed to providing the best in developing manufacturing and applying coatings on medical devices.We are looking for aQuality Control Associate to be part of a positive team-oriented environment. ...

Establish execute review evaluate and optimize laboratory procedures and policies
Perform record and report quality control inspections and testing
Troubleshoot and participate in resolution of administrative or technical problems
Review batch records and supporting documents for production activities and release of product
Initiate facilitate assist and review investigations and associated work for NCPs CAPAs ECOs and failures forlaboratory-related events
Assist with purchase use storage and management of laboratory inventory/supplies.
Investigate customer complaints
Coordinate Material Review Board (MRB) meetings and facilitate material and documentation dispositions as needed
Author and review quality procedures templates forms and reports
Communicate deficiencies safety and/or compliance issues
Compile data and report QMS metrics as required (e.g. special projects product study Management Review)
Support audit preparation and performance audit activities

Skills & Requirements:

Bachelors degree in chemistry biology biomedical engineering or similar Life Science field required
Experience in regulated manufacturing lab setting a plus
Prior experience with ISO 9001 or ISO 13485 and/or experience with QMS documentation and Good Document Practices highly desirable
Ability to report evaluate and interpret scientific data to be successful in this role
Excellent math skills to adequately perform and interpret calculations and test parameters needed
Analytical approach to problem solving; critical thinker; uses data to substantiate decision making
Excellent technical writing skills with great proficiency in spelling grammar formatting and completeness of documentation with extreme detail required
Proficiency with Microsoft Word Excel and Outlook; Prior experience with eQMS or ERP systems highly desired
Ability to complete assigned tasks in a timely manner with minimal day-to-day direction while meeting deadlines
Strong interpersonal and communication skills (verbal/written)
Ability to follow and adhere to all Safety guidelines and processes including wearing appropriate lab gowning and other PPE as required.

Competitive salary eligible for a discretionary bonus
Benefits (medical with HSA component dental vision critical illness and accident insurance)
Life insurance short- and long-term disability paid by the company
Flexible Spending Accounts (FSAs)
401(k) plan with an immediate company match
Paid time off
Education Assistance Program
Rewards and Recognition Program
Parental Leave
Employee Assistance Program
Additional benefits such as the opportunity to leave early on Fridaysbusiness casual dress friendly work environment and fun company events.