Job Summary:

The QA Compliance Associate will be responsible for Cleaning Validation, Periodic reviews, internal/Corporate Audits and cGMP compliance related activities. Ensure processes are followed for the activities and tasks with appropriate documentation.

Area Of Responsibility:

• Develop and maintain the cleaning validation master plan CVMP) Define lifecycle approach• Initial validation periodic review, and re-validation triggers Design and approve cleaning validation protocols and reports. Perform risk assessments for cleaning processes.
• Ensure alignment with cGMP, FDA, and ICH guidelines. Act as SME during audits and inspections; defend cleaning validation strategies.
• Work closely with Cross Functional Team and to ensure compliance activities and site global action management. Ensure timely closure of actions to meet regulatory expectations.
• Handles Quality Metrics Management - supports the collection and reporting of Quality Metrics. Trending of Site Incidents, Product Quality Complaints, Change Controls and CAPA on monthly, quarterly and annually basis as required.
• Support team for IRB/ QRB/ Global actions / Corporate Audit Observations/ Implementation of GQS/ GSOP'S
• Perform assessment of product quality complaints and perform tasks to facilitate the investigations.
• Supports in ensuring FDA Readiness Plan for the facility. Provides support for all regulatory audits, internal/external inspections, and other audits.
• Perform specific assigned tasks and work related to QA processes assigned by the Supervisor/Manager.

Work Conditions:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job in an office, lab, or manufacturing environment. The noise level in the work environment is usually moderate.

Physical Requirements:

The physical demands described here 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 functions.

• While performing the duties of this job, the employee is regularly required to use hands to handle or feel and talk or hear. The employee is frequently required to stand, walk, sit, stoop, kneel, crouch, crawl, push, and bend.
• Must be capable of bending and lifting, moving and/or carrying up to approximately 20 pounds.
• Ability to navigate office, lab, and/or plant floor working environments, stands, ambulates, and reaches.
• Must have the ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/goggles, and safety shoes.

Travel Estimate:

• Up to 5%

Education and Job Qualification:

• Minimum of Bachelor's degree.

• Understanding of GMPs.
• Expertise in software applications such as: MS Word, MS Excel, MS Office, Windows, PowerPoint, Microsoft Outlook, Acrobat Reader, TrackWise or similar QMS, LMS (Learning Management System) etc.
• Knowledge of project management principles, practices, techniques and tools.
• Strong interpersonal and communication, both written and verbal, skills.
• Strong organizational and time management skills; must be able to prioritize and manage multiple assignments simultaneously.
• A self-starter with a hands-on approach and a can-do attitude.
• The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).

Experience:

• Experience working in an international multicultural matrix organization.

The presently-anticipated base compensation pay range for this position is $77,000 to $84,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Long Term Incentive Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).