Sr. Associate Manufacturing Quality Assurance

Job Summary

Responsible for providing Quality Assurance support to Manufacturing Operations relative to the production of commercial and/or clinical products. Responsible for a diverse and challenging set of activities, all of which are related to maintaining quality standards aligned with US FDA cGMP, QSR, ISO and other applicable international regulations and guidance documents.

Risk Management aspects including Quality Alerts, Field Alert Reporting, Product Complaints, Recall, and Site Quality Management Review content. In addition, development of Quality Standards for functions managed within Quality Compliance, and driving overall GxP strategic direction for these quality activities, programs and objectives.

Area Of Responsibility

• Perform in-process checks and inspections; review batch records to ensure that all steps have been performed and verified where applicable, that all limits and specifications have been met and the raw materials and solutions have been tested and released through incoming and in-process inspection process
• Monitoring and tracking of various compliance actions arises due to regulatory inspections and internalcustomer audits. Facilitate review and support regulatory inspection management.
• Draft, facilitate and ensure timely inspection response and monitor CAPA timelines.
• Collaborate with Corporate compliance group and implement global CAPA.
• Support for major health authority inspections at site and provide input and support to inspection readiness/ responses to drive consistency and clarity at the site. Provide oversight of quality activity outcomes resulting from regulatory inspections, commitments and filings.
• Support compliance investigations as needed, in collaboration with others at the site.
• Perform complaint investigations through analyzing returns and reviewing batch records, and provide written reports of findings
• Participate in compliance audits (internal and external) and correct deficiencies as required through the appropriate system
• Interface extensively on a daily basis with all departments.
• Perform all principle duties that affect the quality of products and services within the guidelines of 21 CFR 210/211, 21 CFR 820, ISO 13485, the Canadian Medical Devices Regulation (CMDR), Medical Device Directive (MDD) and other applicable standards, laws and regulations wherever we do business
• Other duties as assigned.

Work Conditions:

Corporate Office Environment

Manufacturing / Production Environment

Laboratories

Warehouse Environment

Field Familiarity Environment

Physical Requirements:

• Must be capable of bending and lifting, moving and/or carrying up to approximately 50 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

• High School Diploma required, Bachelor’s degree in life sciences preferred.
• Must have a thorough knowledge of quality system requirements.
• Demonstrated excellent communication: verbal, written and presentation skills.
• A self-starter with a hands-on approach and a can-do attitude.
• A team building champion driving innovative cross functional synergies.
• Excellent project management and problem solving skills.
• Strong mathematical skills.
• Demonstrated proficiency with Microsoft Word, Microsoft Excel, and Microsoft Outlook programs.

Experience

• Minimum of eight (8) years of experience in the FDA regulated medical device or pharmaceutical industry.
• Experience with Trackwise, EDMS, and Mastercontrol preferred.
• Must have experience with cGMP, QSR and ISO regulations.

• Must have experience performing inspections and investigations.

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee 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 incumbent(s).

The presently-anticipated base compensation pay range for this position is $111,000 to $135,000.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).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives:

Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.