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Compliance Specialist I

Who we are?

We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients’ lives to as many people as possible.

With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 employees.

Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 300 employees.

Your role

Reporting to the Quality Development and Compliance Manager,

JOB SUMMARY:

+ The Compliance Specialist is a critical gatekeeper for quality and safety by assuring that incoming components and raw materials, intermediates, and finished product is manufactured, sampled, packaged, tested, held, and released in a manner consistent with cGMP requirements. The Compliance Specialist effectively conducts and supports problem investigations and disposition of material and finished goods. The Compliance Specialist serves as a frequent inter-organizational contact and may represent the department on teams. Will review and approve a wide variety of GMP related documents. The Compliance Specialist interacts with manager and director levels of management in all departments in developing solutions and conveying information.

ESSENTIAL DUTIES / RESPONSIBILITIES

Batches of Material Dispositioned (25%)

Reviews and approves documentation to assure that packaging components, raw materials, supply items, intermediates, and finished product is manufactured, sampled, packaged, tested, held, and released in a manner consistent with cGMP requirements.

Checks data in a number of systems to ensure there are no product quality concerns.

Responsible for the management and verification of expiration dating on packaging components, operational purchased materials, raw materials, intermediates, bulk and finished product. This includes the verification of expiration/retest dates calculated by ERP systems and manual calculation of expiration dates associated with non-automated calculations.

Performs activities related to the review and release of packaging components, supply items, raw materials, customer/contract materials, intermediates, bulk and finished product received/used/shipped from the Rochester Site

Provides support as required to the QA Technical Complaint system for customer complaint investigations. Conducts and/or participates in quality investigations (involving basic issues) and deviations. The Compliance Specialist will work on investigations and ultimately final product disposition under the guidance of their management or designee (CS II/CS III).

Performs transactions to place or remove a Quality Hold within the ERP system to block or release raw, WIP or finished inventory from shipment or progression as the result of notification from the production floor.

Performs activities related to the review and rejection of packaging components, supply items, raw materials, intermediates, bulk and finished product received/used/shipped from the Rochester Site associated with damaged material, expired material, inventory management and deviations.

Performs activities related to the review and Re-Release of materials from update testing, returns, material to material transfers and deviations.

Provides support to the annual product review system.

Supports quality investigations.

Effective & Efficient Processes (30%)

Informs management immediately of any quality-related concerns and risk to the organization.

Ensures the development, documentation and implementation of standardized processes for key business functions. Develops quantitative techniques to monitor process performance.

Evaluates effectiveness of SOP, identifies changes that would enhance the process, and ensures that all change control documentation is implemented.

Identifies and implements ways to streamline and improve efficiency while maintaining process effectiveness. Challenges the way it has always been done.

Utilizes understanding of regulatory environment and industry trends to identify ways to improve process quality and compliance.

Identifies the impact of available technology on business processes and ensures that it is used to maximum advantage.

Ensures stakeholders are appropriately trained on the process and any process changes.

Customer Required Documentation (30%)

Reviews and Approves Certificates of Analysis (COA) based on finished product specification requirements which are completed accurately and consistent with format and organizational standards.

Reviews and Approves Certificates of Compliance (COC) based on finished product specification requirements and are completed accurately and consistent to format and organizational standards.

Reviews and Approves export labels to provide for the timely, accurate transport of goods.

Prepares, Reviews and Approves customer requested documentation as requested for packaging components, operational purchased materials, raw materials, intermediates, bulk and finished product. Supports as required in quality investigations associated with documentation provided to customers.

Guidance on Documentation and Training Requirements (15%)

Assists other functions in the organization in understanding the standards for effective documentation.

Assists other functions in the organization with ERP related concerns.

Assists as backup for new hire orientation for cGMP modules.

Your profile

+ C. REQUIRED EDUCATION:

Equivalent Quality Assurance experience in FDA regulated environment

D. SPECIFIC SKILLS:

An understanding of current regulatory requirements.

QA/compliance experience in manufacturing, facility operation, laboratory compliance and quality systems.

Must be able to recognize situations where there is a potential impact on product quality, safety, identity and purity.

E. PHYSICAL REQUIREMENTS/ENVIRONMENT:

Traditional office environment, with frequent visits to other areas of the facility, including production areas, loading docks, and laboratories.

Must be able to work on a computer for extended periods of time.

Must wear safety glasses and other protective items as required.

Sitting 75% of the day; standing or walking 25%.

Compensation range

65,000.00 - 75,000.00 USD

*The referenced compensation range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

A Smarter Total Compensation Package

At Unither, your base salary is just the beginning. Our Total Rewards include:

+ 100% employer-paid medical premiums (a $2,000–$6,000+ annual value)

+ 401(k) contributions: 6% match plus an additional 4% company-funded contribution

+ HSA contributions with wellness incentives

+ And more—because we invest in your health, your future, and your peace of mind.

It’s a package designed to reward impact—not just hours worked.

More Than Just a Paycheck

At Unither, we don’t just offer competitive hourly wages—we also pay 100% of your medical premiums.That means no paycheck deductions for your healthcare, which can be worth an extra $1 to $3.50 an hour in your pocket compared to jobs where you pay part of the premium.

Learn more about us:

We are a dynamic company driven by a spirit of victory and are therefore pursuing strong growth while maintaining a close relationship with our customers and employees.

Our culture is based on 5 values: Respect, Responsibility, Trust, Courage and Innovation. We are committed to bringing these values to life with our employees by granting them a high degree of autonomy in the exercise of their profession and by encouraging their initiatives.

We are committed to providing them with working conditions and atmosphere that is conducive to their development and the expression of their potential.

We propose you to integrate a site that values the meaning of work and that entrusts our employees with a high level of responsibility.

Join us and make a difference!