Quality Compliance Associate Jobs

• Knowledge, Skill and Abilities

• Good project management skills

• Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.

• Must have basic English written and oral communication skills adequate to communicate with other team members.

• Minimum of 5-8 years of experience in Quality, or related field in the medical products industry.

Job Title: Quality Associate III

Pay: $110-115/ Hourly based on experience

• Ability to manage internal DSCSA deviation investigations through resolution and approval.

• Requires business and application experience in warehouse operations including managing orders, inventory, warehousing, and logistics.

• Well versed in general IT capabilities.

• Proven ability to function in a self-directed environment, can manage multiple projects simultaneously

10+ years of related experience

Ensure timely completion of all mandatory training requirements. Knowledge, Skills, and Abilities:

Review daily manual reports for OFAC screening, documenting the reviews and reporting findings to management as necessary.

Organized, detail- oriented, self-motivated, and strong communication, writing, and follow-up skills

Ability to work dependably and consistently under team constraints, and to manage time efficiently and effectively

Strong research, analysis, communication, writing, and follow-up skills. Ability to identify, escalate and resolve a problem

Understanding of compliance and BSA/AML/OFAC regulatory requirements and implications

Assist with the development and management of the auditor qualification, training requirements and develop effective auditing tools.

Previous Quality Assurance experience that provided the knowledge, skills, and abilities to perform the expectations outlined in this job description.

5+ years in an internal and vendor auditor role for in GMP/GCP /GLP/GPvP/GDP fields. Quality Auditor / Manager Certification, preferred.

Experience with technologies used to conduct audits in a remote/virtual environment.

Must have the ability to build and maintain positive relationships with department management, peers, and other colleagues across the organization.

Self-motivated with the ability to take initiative, ownership and manage multiple responsibilities while shifting priorities quickly under tight timelines.

Performs daily tasks including data entry, track returned finished goods movement through the facility, and assist others in understanding quality issues.

Understanding and working knowledge of quality tools and problem solving methodology.

Computer skills required including Office (Word, Excel).

Inspects a selection of finished product (QA) against customer expectations and NB Global Standards.

High school diploma or equivalent and 5 plus years in a manufacturing and/or a quality assurance environment. Associate degree preferred.

Ability to recognize and problem solve root cause(s) of defective product.

o Serve as the interface to all other regional QA functions during launch and E2E product management

A minimum of ten (10) years of relevant experience required.

Strong working knowledge of dietary supplement regulations with success in leading a dietary supplement organization preferred.

A minimum of a bachelor’s degree required. Post graduate degree preferred.

Demonstrated ability to work on complex or ambiguous issues autonomously, with little/no daily direction.

Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!

Manage record requests, subpoenas, interactions and communications with regulatory officials as it relates to region specific requests and needs.

Minimum 2 years clinical experience in a home health environment

Familiarity with clinical documentation requirements in home health environment

Computer literate with working knowledge of Microsoft Office and ability to learn a variety of other software applications

Previous medical records review experience preferred

Ability to develop and maintain strong working relationships with clinical managers

Time Management: Adhere to daily time tracking requirements, ensuring all tasks and responsibilities are accounted for.

Insurance Maintenance: Oversee and update the company's insurance records, ensuring timely renewals, accurate invoice tracking, and effective billing management.

Great Ongoing Learning and Development opportunities offered for certifications and tuition reimbursement

Regulatory Compliance: Manage the company's state registration and filing necessities. This includes keeping track of renewal dates and ensuring timely payments.

0-1 years understanding of accounting and finance as it relates to financial reporting and budgeting.

Strong analytical, critical thinking and problem-solving skills.

Excellent writing skills and the ability to succinctly convey information to senior business and compliance management.

Keeping management apprised and recognizing when to escalate issues as needed.

At least 3 – 5 years of BSA/AML banking compliance or regulatory experience.

Experience working with FFIEC Exam Manual high risk customer types, including conducting CIP, KYC, and CDD / EDD.

Experience with transaction monitoring and case investigations, including Suspicious Activity Report filing.

CAMS and/or ACFCS certification desired.

Assist with the development and management of the auditor qualification, training requirements and develop effective auditing tools.

Previous Quality Assurance experience that provided the knowledge, skills, and abilities to perform the expectations outlined in this job description.

5+ years in an internal and vendor auditor role for in GMP/GCP /GLP/GPvP/GDP fields. Quality Auditor / Manager Certification, preferred.

Experience with technologies used to conduct audits in a remote/virtual environment.

Must have the ability to build and maintain positive relationships with department management, peers, and other colleagues across the organization.

Self-motivated with the ability to take initiative, ownership and manage multiple responsibilities while shifting priorities quickly under tight timelines.

High attention to detail, high efficiency, and excellent time management skills.

Excellent project management and organizational skills, including ability to work on multiple projects simultaneously in a fast-paced and dynamic environment.

Experience using Chainalysis or Elliptic.

Advanced research and analytical skills.

Expert oral, written, and interpersonal communication skills with the ability to distill and present complex information accurately and clearly.

This is a remote-first position which may require some infrequent travel to our Lancaster, PA office location.

Collect and publish quality and compliance metrics and reports trends to management

Track and oversee document management to assure quality compliance

Coordinate / revise / manage QA SOPs and product specifications

Document and coordinate product risk assessments to assure compliance with Quality System requirements

Strong analytical, organizational and problem solving skills

Excellent written and verbal communication skills

· Risk management experience is a plus

· Create reports for senior management and external stakeholders.

· Strong knowledge of BSA, AML, Reg E rules and regulations

No 3rd party applicants (cannot work C2C), please

· Assist in establishing, maintaining, and testing a complex compliance program for a fintech startup.

· Create and implement productive and efficient company policies and guidelines.

Responsibilities include but are not limited to:

Assist with developing, drafting and maintaining compliance policies and procedures outlining firm requirements, regulations and best practices

Coordinate with internal stakeholders to assist with new business initiatives and regulatory requirements

3-5 years of compliance, legal or regulatory experience at a registered firm,

Excellent verbal and written communication skills

Create and deliver compliance trainings

Excellent oral and written communication skills with the ability to communicate at all levels of management

Complete other regulatory compliance tasks assigned by management.

Sound and tested experience exercising judgment including communication, relationships and the accurate presentation of materials required of high-stakes engagements

Highly organized individual with strong attention-to-detail skills

Experience engaging with federal or state regulators a plus

Excellent interpersonal and presentation skills

· Manage plan projects and data needs

· Knowledge of department and company systems (PSL, SF, Flexman, etc.) as required for your position

· Onboarding new clients in company systems

· Create, maintain, and enter information into databases

· Invoice for services and products as necessary

· Assist with projects and audits

oStrong writing, communication, training, and research skills with attention to detail

oStrong organizational skills and ability to establish priorities among a wide array of projects

·Strong MS office skills required

·Working knowledge of export regulations referenced required.

Position can be remote or hybrid.

Vacation/Sick ( 2 weeks(1-2)3 weeks(3-5), 4 weeks (6 and beyond)

Analytical, technical, and technology skills with proficiency in basic Office software, including Excel and Word

Must be able to demonstrate strong organizational and problem-solving skills with attention to detail

Must be able to demonstrate strong oral and written communication skills

Drafting regulatory policies and procedures

Analyzing clients’ trading practices, including evaluating personal securities transactions

Ensuring compliance violation reports are properly investigated and appropriate action is taken and documented, including adherence to client policies and procedures

Analytical, technical, and technology skills with proficiency in basic office software, including Excel and Word

Must be able to demonstrate strong organizational and problem-solving skills with attention to detail

Must be able to demonstrate strong oral and written communication skills

Ability to analyze industry regulations; adapt and develop policies and procedures to meet compliance requirements

Conducting forensic testing and verification of internal controls for clients to comply with prevailing rules and regulations

Assisting with managing clients’ registrations with applicable regulators, including the SEC and CFTC

Prior work experience in compliance (preferably securities)

Responsibilities include but are not limited to:

Performing daily trade reviews using proprietary systems and databases

Assisting with maintaining Compliance policies and procedures

Assisting with various audits, regulatory inquires and filings

Conducting monthly testing of client confirmations and best execution reviews under supervision