Quality Assurance Specialist, Medical Communications Job at Parexel

Center Quality Specialist

Essential Job Responsibilities and Duties and Qualifications

Location

United States , Fort Pierce

Salary:

Not provided

Assessfirst

Expiration Date

Until further notice

Requirements

High school diploma, GED or equivalent required
Associates degree preferred or a minimum of (3) three to (6) six months quality or plasma industry experience required
Strong verbal and written communication skills
Must have above average problem-solving and decision-making abilities
Proficiency with computers
Must have explicit attention to detail
Must have excellent analytical skills, organization skills, and follow-up
Ability to read and interpret documents such as safety rules, operating and maintenance instruction, and procedure and technical manuals
Ability to interpret a wide variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
Use hands to handle or feel objects, tools, or controls

Job Responsibility

Perform donor record file review
Perform equipment quality control review - daily, weekly, monthly, semi-annual and annual
Review medical reports and communication
Perform reviews of equipment incidents
Verification and release of sample shipment
Responsible for the inspection and release of incoming supplies
Initiate deviation reports as needed
Perform Weekly employee observations
Assist the Manager of Quality Assurance with compliance of all state and federal regulations, FDA-approved Standard Operating Procedure Manual, Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP), Occupational Safety and Health Administration (OSHA), and internal company procedures
Reviews the documentation of unsuitable test results and the disposition of the associated units

Fulltime

Quality Specialist – Product Compliance

Undertaken batch review for a variety of Products in Poland that require QP batc...

Location

Poland , Warsaw

Salary:

Not provided

Theramex

Expiration Date

Until further notice

Requirements

Experience working in Quality Function within the Pharmaceutical industry
Some experience of key areas of Quality Assurance and Pharmaceutical Quality Management Systems (Complaints, CAPA, Deviation, Change Control)
Basic Knowledge of the Pharmaceutical GxP regulations
Able to foster strong cross-functional relationships
Influence, interpersonal, verbal, and written communication skills
Able to respond positively to, and effectively implement, change
Digitally Savvy
Fluency in both English and Polish to handle communication with healthcare authorities in Poland
A degree or equivalent in a relevant scientific subject is desirable

Job Responsibility

Performing a review of manufacturing records for batches of medicinal products certified by Theramex QP
Batch Review all MIA Products Prior to QP Certification
Establish a close working relationship with the Contract Manufacturers and internal stakeholders (Supply Chain, Regulatory, Medical, Marketing) for assigned products
Investigation and resolution of complaints with CMOs
Determining and implementing robust CAPAs as required
Assessment and approval of deviations
Managing and approval of change controls
Creation and Maintenance of Quality / Technical Agreements
Ensuring CMO’s are supplied and adhere to Compliance Files / Marketing Authorisations
Support of on-site audits and visits

Quality Assurance Manager

The Quality Assurance (QA) Manager provides site-specific quality oversight and ...

Location

United States , Fenton

Salary:

80000.00 - 90000.00 USD / Year

Strive Compounding Pharmacy

Expiration Date

Until further notice

Requirements

High School Diploma or GED
Minimum of five (5) years experience in a quality or manufacturing department within a pharmaceutical, medical device, or allied health science environment
Proven experience in aseptic operations and working in regulated environments
Strong knowledge of pharmaceutical quality assurance practices, including deviation management, CAPA, change control, and documentation review
Ability to analyze and interpret data, identify trends, and recommend preventive actions
Strong organizational, communication, and problem-solving skills
Proficiency with Microsoft Office Suite and quality management systems (QMS)

Job Responsibility

Supervise the site Quality Assurance team, including task assignment, workload prioritization, timecard management, performance reviews, coaching, and discipline as needed
Lead QA candidate interviews and oversee onboarding, training, and competency development
Conduct routine QA team meetings and cross-department quality huddles
Train QA personnel to ensure proficiency in documentation, review, and compliance expectations
Conduct regular reviews of compounding, production, and cleaning documentation (batch records, cleaning logs, inventory sheets) for accuracy and completeness
Verify and reconcile all labeling to ensure control and accountability
Review temperature monitoring and Building Management System (BMS) alarms to verify timely investigation and resolution
Confirm that product test results meet specifications prior to release
Review documentation for media fill and process validation activities
Approve equipment calibration, preventive maintenance, and certification records to ensure adherence to schedules and standards

What we offer

Employer paid healthcare coverage available after 30 days of employment
Choice of an FSA/HSA
Voucher for new hire scrubs (if applicable)
Parental leave
401(k) plan with matching contributions
Weekends and holidays off
FREE COMPOUNDED MEDS to employees and immediate family members

Fulltime

Quality Process Improvement Specialist

This role will require the use and application of quality and process improvemen...

Location

United States , Tucson

Salary:

Not provided

Tucson Medical Center

Expiration Date

Until further notice

Requirements

Bachelor’s degree in healthcare, Nursing, Communications, Finance or related field or equivalent combination of experience and education
Five (5) years of experience in healthcare field
Knowledge with project facilitation from start to finish
Knowledge of root causes creating process problems
Skill in verbal/written communication and report development
Skill in public speaking and presenting information
Skill in developing and maintaining working relationships
Skill in applying and teaching exceptional customer service
Ability to develop, interpret and read detailed documents, contracts, proposals
Ability to listen and accurately interpret others’ communication

Job Responsibility

Use and application of quality and process improvement tools, and methods for developing and improving processes
Assist with engaging leaders to empower staff to drive improvements
Perform and oversee ongoing Quality Improvement activities to assure patient safety and evidence based practice, as well as, timeliness, accuracy and compliance
Work independently and in collaboration with the medical staff and other members of the health care team in developing ongoing evaluation programs to identify, resolve, and report opportunities to improve patient care
Creates well-developed oral and written communications
Organizes and delivers professional presentations
Assists with organizing and coordinating process improvement using Lean and quality improvement tools and methodology
Develops rapport with customers, suppliers, leaders, and employees
Coaches, mentors, teaches, and develops staff members in use and application of quality and process improvement tools
Assists with facilitating and motivating cross-functional work groups

Fulltime

Product Specialist

Product Specialist of Cosmo Intelligent Medical Devices.

Location

Italy , Rome

Salary:

Not provided

Cosmo Intelligent Medical Devices

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a scientific discipline, preferably Biomedical Engineering, Life Sciences, or a related field
At least 3 years of experience as a Product Specialist or similar role in the medical device industry
Strong knowledge of the medical device sector, including regulatory requirements and compliance standards
Excellent communication and presentation skills, with the ability to convey technical knowledge to non-technical audiences
Analytical skills to assess market data and develop effective sales strategies
Willingness to travel frequently to meet clients and attend industry events
Fluency in English, both written and spoken

Job Responsibility

Build and maintain strong relationships with existing customers by planning and organizing regular visits to ensure continuous support and identify new sales opportunities
Develop new business opportunities and convert them into long-term partnerships, contributing to sales success
Provide technical support and clinical training to customers on the effective use of medical devices, ensuring a high level of customer satisfaction
Coordinate and organize hands-on demonstrations, presentations, and educational programs for healthcare professionals, representing the company at congresses and symposiums
Actively collaborate with internal departments, including R&D, marketing, and quality assurance, to ensure effective product strategy alignment

Principle Quality Assurance Process Specialist

Be part of something altogether life-changing! Working at Cytiva means being at ...

Location

Sweden , Uppsala

Salary:

Not provided

Danaher Corporation

Expiration Date

Until further notice

Requirements

Bachelor's Degree, or equivalent experience in regulated medical device, pharmaceutical or life sciences industry
Quality Assurance/ Quality Engineering experience in a GMP environment
Demonstrated good collaboration skills and expertise to effectively communicate the organization
Understanding QMS and regulatory requirements including but not limited to FDA CFR 21 820, ISO 13485 and ISO 9001
Exceptional analytical, problem solving & root-cause analysis skills as well as proven track record working cross – functionally and at global level

Job Responsibility

Leadership of the end-to-end QMS change control process, providing subject matter expertise to all sites and global functions
Drive the standardisation & best practise of the QMS change control process across all sites and functions, covering all aspects of the product life cycle management and compliance
Ownership and accountability for key global change controls concerning the QMS or major quality related changes. To include leadership of the Global Cross Functional Review Team
Working with the DBS tools, to improve effectiveness and efficiency of other key quality processes as required, in line with the customer expectations
Ownership of the KPI replated to Change Controls, specific to on time completion and effectiveness check. Prepare reports on KPI, identify trends and improvement opportunities