Compliance Specialist

PL Developments, also known as PLD, is a leading manufacturer, packager, and distributor of over-the- counter (OTC) pharmaceutical products and costumer healthcare goods.

SUMMARY

The Compliance Specialist is responsible for working independently to support quality and vendor management activities. A solid understanding of cGMP regulations, exceptional attention to detail, strong data entry capabilities, and excellent verbal and written communication skills is necessary. This role is critical in ensuring compliance with both regulatory standards and internal requirements.

Work Schedule: Monday – Friday, 9:00am – 5:30pm (Hybrid)

JOB QUALIFICATIONS:

• Bachelor’s degree in a scientific or allied health field or Associates with relevant work experience
• Minimum of 2-4 years of quality/ regulatory compliance experience in the pharmaceutical or relevant industry
• High attention to detail, organizational, communication (written and verbal), and time management skills
• Proficient in Microsoft Word, Excel, and PowerPoint
• Strong teamwork, conflict resolution, and interpersonal skills
• Knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting, vendor management, regulatory compliance and ICH guidelines

POSITION RESPONSIBILITIES:

• Drafting and enforcing quality-related agreements between CMOs and Suppliers/Vendors
• Assisting quality system owners (deviation, change control, CAPA, etc.) with ensuring compliance to procedure requirements
• Preparing internal audit schedules, tracking internal audit observations, and maintaining related documentation
• Facilitating scheduling of external audits as a part of vendor management program
• Initiating qualification processes utilizing part 11 validated QMS system, review of qualification documents, and document maintenance of vendors onboarding and maintenance
• Assist in scheduling vendor audits
• Preparing, evaluating, and maintaining vendor scorecards on an annual basis
• Participate in continuous improvement initiatives within the team
• Maintaining Compliance Metric data to support process improvement activities
• Perform all other related duties as assigned

Hourly Range: $24.00/hr - $26.50/hr 

BENEFITS:
PLD is a proud employer offering many corporate benefits, including:

⦁ Medical and Dental Benefits

⦁ Vision

⦁ 401K with employer match

⦁ Group Life Insurance

⦁ Flex Spending Accounts

⦁ Paid Time Off and Paid Holidays

⦁ Tuition Assistance

⦁ Corporate Discount Program

⦁ Opportunities to Flourish Within the Company

 

PL Developments is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

 

#HP1