Job Summary
The Sr. Associate Compliance provides scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP) and Quality Management System standards, compiles monthly Quality metrics for internal and corporate review, and analyzes trends to implement corrective and preventive actions to mitigate adverse trends.
Area Of Responsibility
Support and collaborate with multiple departments to ensure timely documentation, root cause analysis, and QA closure of Stage II OOS investigations and OOT investigations
Work directly on technical investigations relating to Product Quality Complaints
Provide verbal and written responses/resolutions to customers regarding product quality Complaints or product inquiries
Participate in other quality investigations and risk assessments as requested to perform review of documents, processes, testing, etc.
Plan and coordinate routine and non-routine projects requiring independent judgment, evaluation and selection of compliant scientific techniques
Perform statistical analysis of critical attributes and trending of QMS events for each commercial product and provide a scientific rationale for the outcome of the conclusion presented in the APQR.
Prepare Annual Product Quality Review (APQR) report for each commercial product as per predefined timeline.
Compile and report on Quality metrics at monthly Quality meetings, creating presentation materials to identify trends, quality and compliance risks, and make recommendations for changes to processes, procedures, and training, as applicable
Manage electronic Quality Management System (TrackWise)
Implement electronic Quality Systems, such as eQMS, EDMS, and LMS, providing procedures and training for employees to effectively use the electronic Quality Systems
Develop presentation monthly for QRB meeting based on eQMS, Quality Matrix and Monthly Quality investigation Board (QIB) meeting.
Follow up with stake holders for timely closures of all open QMS documents and update TW accordingly. Finally, present the status/findings to QRB meetings.
Drive projects to improve the QMS for compliance through Trackwise (TW), efficiency, or corporate needs
Author/revise standard operating procedures (SOPs) and test methods, as required
Other duties as assigned
Work Conditions:
Office
Physical Requirements:
Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, stoop, kneel, crouch or crawl, climb or balance
Talk or hear
Close vision
Computer/office machines
Lift up to 10 lbs.
Some travel outside of company facility required
Travel Estimate
Up to 5%
Education and Job Qualification
B.S. in chemistry or related scientific field
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
Experience
Minimum 6-8 years related experience in a pharmaceutical manufacturing environment
Working knowledge of cGMPs, GLPs
Strong knowledge of Trackwise to handle electronic Quality Manage System (eQMS) data
Strong knowledge of instrumental and wet analytical chemistry
Strong knowledge of microbiology testing
Strong working knowledge of MS Office software
Preferably knowledge to handle SAP, EDMS, LMS, Master Control etc…
Experience with the manufacture and testing of radiopharmaceuticals is strongly preferred
Strong familiarity with regulatory / compliance environment (cGMP, GLP) associated with parenteral drug manufacture
The presently-anticipated base compensation pay range for this position is $98,000 to $119,500. 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. 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.
United States - MA - MA - Boston
June 14, 2024
Detailed Description of Services: • The Storage\\Backup Engineer is responsible for helping the senior storage\\backup engineer for managing and maintaining our storage and backup environments both OnPrem and in the cloud. • Role is to help assist in the efficient operation, functionality,...
United States - MA - MA - Spencer
June 13, 2024
Are you an internal caregiver, student, or contingent worker/agency worker at UMass Memorial Health? CLICK HERE to apply through your Workday account. • Exemption Status: • Non-Exempt • Schedule Details: • Holidays - Every Other Holiday, Monday, Tuesday, Weekends - Every Other...
United States - MA - MA - Boston
June 18, 2024
Summary • The Guest Services Agent (GSA) is responsible for consistently delivering results that contribute to the mission and overall success of the hotel by accomplishing performance objectives covering the front desk and is support for the Operations Manager. The GSA serves as the point...
United States - MA - MA - Oak Bluffs
June 9, 2024
Description • Job Summary and Qualifications • Obtains quality radiographs of patients within the department as well as with portable equipment in an acceptable timeframe. • Complies with radiation safety guidelines for patient and self. Utilizes Personal Protective Equipment....
United States - MA - MA - Chelsea
June 24, 2024
$7,500 Sign-On Bonus - Free Weekly Groceries • Nursing Supervisor | Weekends | Katzman Center For Living • At Chelsea Jewish Lifecare, we are committed to not only providing compassionate and comprehensive care for our residents, but also maintaining a culture where our staff is not just...
United States - MA - MA - North Adams
June 29, 2024
Setting: Skilled Nursing Facility • We're seeking a full time Physical Therapist to provide expert physical therapy to patients with injuries or illnesses to help them improve movement, manage pain, and/or prevent the loss of mobility. Learn more about a career as a traveling PT. • Minimum...
NortheastArc Clinical Services
United States - MA - MA - North Reading
June 29, 2024
*Shifts:* Monday, Tuesday, Wednesdays, Saturday, Sunday-8am-4pm, 4pm-10pm. Thursday, Friday-4pm-10pm. • Patient Details:* 44 year old female • Quadriplegic Cerebral Palsy • PO Feeding • Respiratory treatments (nebulizers, PRN Trach and nasal suctioning) • Ventilator use...
United States - MA - MA - Springfield
June 12, 2024
*Summary: • Schedule: Saturday & Sunday 630a-3pm • Location: BMC Springfield • This position is responsible for assuring that the basic functions in Health Information Management is completed in a satisfactory manner. This includes assuring confidentiality of all patient health...
Assisting Hands of Boston Northwest
United States - MA - MA - Natick
June 25, 2024
Benefits: • Company parties • Competitive salary • Flexible schedule • Free uniforms • Health insurance • Opportunity for advancement • Assisting Hands - Boston Northwest is looking for reliable, caring and experienced caregivers to join our growing team! •...
Shawmut Design and Construction
United States - MA - MA - Boston
June 27, 2024
Since our founding in 1982, Shawmut Design and Construction (a 100% employee-owned company) has been recognized as a • Best Place To Work • 70 times by our employee-owners. • At Shawmut, you will have the opportunity to own your career and deliver impact within our culture of...
United States - MA - MA - Gardner
June 27, 2024
* • + Models and delivers a distinctive and delightful customer experience. • Registers sales on assigned cash register, provides customers with courteous, fair, friendly, and efficient checkout service. • In accordance with state and federal regulations, assists the pharmacist, under...
United States - MA - MA - Spencer
June 22, 2024
Are you an internal caregiver, student, or contingent worker/agency worker at UMass Memorial Health? CLICK HERE to apply through your Workday account. • Exemption Status: • Non-Exempt • Schedule Details: • Weekends - One Full Weekend a Month • Scheduled Hours: •...
United States - MA - MA - Athol
June 28, 2024
* • + Models and delivers a distinctive and delightful customer experience. • Registers sales on assigned cash register, provides customers with courteous, fair, friendly, and efficient checkout service. • Customer Experience • + Engages customers and patients by greeting them...
United States - MA - MA - South Weymouth
June 4, 2024
Job Title: Clinic Nurse • At ConvenientMD we're on a mission to make good health more convenient for all - working to improve how patients and providers experience healthcare in New England. To support this belief, we're building a team of dedicated professionals who genuinely care about...
Applewood Center Winchester NH
United States - MA - MA - Northfield
June 28, 2024
Applewood Center is Now Hiring full-time LNAs! Evening Shift. As a full time employee, you may be eligible for Mod Comp, which is an additional 25% on your base rate of pay! APPLY TODAY! Benefits • Nursing Student Loan Debt Repayment and Tuition Assistance • Variable compensation plans...
United States - MA - MA - Framingham
June 9, 2024
Description: • Bachelor's degree in business administration, Information Systems, Computer Science, or related field. • Proven experience working as a Business System Analyst or similar role, with a focus on customer master data management. • Expertise in MDM, and customer matching...
United States - MA - MA - Boston
June 9, 2024
Responsibilities: • Ensure patient safety and comfort to patients recovering from anesthesia • Monitor the patient's level of consciousness and vital signs • Provide reassurance and education to patients and family members • Assess patients, deliver care to ventilator dependent...
NortheastArc Clinical Services
United States - MA - MA - South Hamilton
June 29, 2024
*Shifts:* • Saturdays and Sundays 8a-flexible end time. Mondays, 8a-5p. • Patient Details: • 5-year-old male - seizure disorder, GJT, oxygen. • About NortheastArc-Clinical Services:*NortheastArc-Clinical Services* is a nonprofit Medicaid/Medicare-certified home healthcare agency...
United States - MA - MA - Dedham
June 29, 2024
We save lives while providing the opportunity for people to realize their healthy selves.: • Residential Adolescent Therapist • Walden Behavioral Care • Dedham, MA • Walden Behavioral Care is one of the only rapidly-growing, leading national specialty healthcare systems dedicated...
United States - MA - MA - Springfield
June 7, 2024
*Video Monitoring Technician • Baystate Health, a nationally recognized leader in healthcare quality and safety, and home to Baystate Behavioral Health Department, is looking for a part-time Video Monitoring Technician (VMT) to join our team in Springfield, MA. • _Resume required with...
United States - MA - MA - Sudbury
June 11, 2024
Assisting Hands - Boston Northwest is looking for reliable, caring and experienced caregivers to join our growing team! • Want to learn more? Use this link to schedule a time to talk speak with our Hiring Coordinator, Zach Tarazi- • Benefits: • Competitive pay rates • Health and...
United States - MA - MA - Framingham
June 28, 2024
Sodexo is an EEO/AA/Minority/Female/Disability/Veteran employer. Sodexo is committed to upholding the spirit and principles of the Rehabilitation Act of 1973 and the 1998 amendment to the Act. If, due to a disability, you require a reasonable accommodation to navigate this site and/or complete the...
United States - MA - MA - Salem
May 21, 2024
Nomad Health seeks an experienced Psychiatry registered nurse for a travel assignment in MA. Take the next step in your healthcare career and join Nomad Health as a Psychiatry travel nurse. As a traveler with Nomad, you get access to industry-leading pay, outstanding benefits, and our knowledgeable...
United States - MA - MA - Wellesley Hills
June 12, 2024
Maxim Healthcare Services is seeking a Licensed Practical Nurse (LPN)/Licensed Vocational Nurse (LVN) to work one on one with a patient in the school setting • Why Join Maxim: • Competitive Pay & Weekly Paychecks • Health, Dental, Vision, HSA and Life Insurance • Paid Time Off...
United States - MA - MA - Spencer
June 14, 2024
Are you an internal caregiver, student, or contingent worker/agency worker at UMass Memorial Health? CLICK HERE to apply through your Workday account. • Exemption Status: • Non-Exempt • Schedule Details: • Sunday through Saturday • Scheduled Hours: • Variable •...
United States - MA - MA - Fitchburg
June 7, 2024
Find yourself here. Aveanna is compassion and passion rolled into one inspired purpose. It's anything you want to find and everything you're looking for. It's a place where caring is more personal, because it happens right in the comfort of home. Come see what's waiting for you when you come to...
United States - MA - MA - Haverhill
June 28, 2024
Maxim Healthcare in Needham is hiring for a Licensed Practical Nurse (LPN) to work with Pediatric and/or Adult patients in their own homes. • Why Join Maxim: • Competitive Pay & Weekly Paychecks • Health, Dental, Vision, HSA and Life Insurance • Paid Time Off • 401(k)...