Senior Compliance Training Associate

Job Summary

Manage the site’s training program covering cGMP requirements, and corporate policy, and other topics to a broad spectrum of professional individuals that serve company’s manufacturing plant, research and development laboratories, and general business operations.

Reporting to the Site Compliance Head, and using independent judgment; apply ISO, cGMP, and FDA procedures and regulations to activities involving quality assurance and compliance for pharmaceuticals and medical devices.

Area Of Responsibility

• Evaluate training needs and participate in the delivery of training materials for the company including Manufacturing, Quality, and Support groups ensuring compliance with the training policy and all training procedures
• Administer the LMS and coordinate training activities, including scheduling sessions, updating training records, generating reports, etc.
• Maintain a compliant training record keeping (data entry and hard-copy files) system
• Assist  in developing curricula of on-the-job training requirements including appropriate documentation, qualifying trainers, and assuring approved training content and working with area supervision, manages assignments within the Learning Management System (LMS)
• Prepare training completion metrics for dissemination at Quality Review Board meetings
• Work with area managers to determine training frequency/re-training intervals based on roles and responsibilities
• Assist in developing training assessment tools, such as tests and competency evaluation worksheets
• Review Quality records to ensure conformance to approved procedures and cGMP

• Maintain an annual scheduled training calendar, ensuring on-time delivery of annual GMP training and other GxP trainings
• Act as Single Point of Contact (SPOC) between Corporate Documentation & Training group and site, working towards harmonization of the site training and site procedures with Corporate expectations
• Creates and manages documentation requests in electronic systems such as EDMS, Master Control, and Trackwise. in a timely manner to meet established deadlines
• Assists in monitoring documentation due for annual periodic review
• Other duties as assigned

Work Conditions:

• Office area
• Manufacturing floor
• Labs
• Warehouse

Physical Requirements:

• Sit, stand, walk, use hands and fingers to handle or feel, talk, hear, stoop, kneel, crouch or crawl
• Lift up to 10 lbs.
• Close  vision
• Gowning, lab coat, safety glasses, gloves in clean room areas
• Operate computer/office machines

Travel Estimate

• Up to 5%

Education and Job Qualification

• B.S. in related field or equivalent required
• Ability to present self in a professional, credible manner and communicate effectively at all levels of the organization
• Ability to prioritize and organize own work, multi-task, meet deadlines and keep commitments
• Excellent administrative & organization skills
• Positive attitude; values others and works well independently and in a team environment
• Excellent verbal, written and interpersonal communication skills

Experience

• 4+ years of related experience in a pharmaceutical/ drug or medical device industry , or other FDA regulated industry
• Working knowledge of cGMPs and ISO Standards preferred
• Experience with administration of Learning Management Systems (LMS), Electronic Data Management System (EDMS) and Master Control required
• Experience in Manufacturing and Quality positions, preferably both
• Experience performing work that requires decision making and the consistent exercise of independent judgment and discretion
• Strong working knowledge of a Quality Management System (QMS) and adherence to 21 CFR Parts 210, 211; aseptic drug manufacturing experience a plus
• Superior internal and external customer service/people skills
• Ability to manage multiple responsibilities and projects in a fast paced environment, while performing in an efficient manner
• Public speaking, instructional presentation skills and/ or instructor-led training experience required
• Must have a strong understanding of FDA and other cGMP regulatory requirements as they relate to industrial and non-industrial tasks at a biotech manufacturing facility and/or R&D facility
• Must have excellent computer skills, including MS Word, PowerPoint and Excel
• Experience with commercially available CBT authoring tools a plus

The presently-anticipated base compensation pay range for this position is $85,000 to $104,000. 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. 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.