Associate, Compliance

Job Summary

The Associate Compliance provides support with the assessments of the Global procedures as well as site procedures to ensure compliance with current Good Manufacturing Practices (cGMP) and Quality Management System standards. Also compiles monthly Quality metrics for internal and corporate review, and analyzes trends to implement corrective and preventive actions to mitigate adverse trends.

• Support and collaborate with multiple departments to ensure timely documentation, root cause analysis, and QA closure of Stage II OOS investigations and OOT investigations
• Participate in other quality investigations and risk assessments as requested to perform review of documents, processes, testing, etc.
• 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 site-to-corporate communication on all of the Global SOPs and Billerica site SOPs
• Require excellent communication and organizational skills to lead meetings and work with site cross‑functional teams
• Drive the implementation of gap assessments and meet critical corporate site timelines
• Maintain understanding of Quality systems regulations, CAPA and change control requirements
• Understand technical writing
• Manage electronic Quality Management System (Trackwise)
• Implement electronic Quality Systems such as QMS, EDMS, and LMS, providing procedures and training for employees to effectively use them
• Develop presentation monthly for QRB meeting based on assessments of Global Procedures, Quality Matrix and Monthly Quality investigation Board (QIB) meeting
• Drive projects to improve Global Procedures for compliance through Trackwise (TW), efficiency, or corporate needs
• Author/revise standard operating procedures (SOPs) as required
• Other duties as assigned

• Seniority Level: Mid‑Senior level
• Employment Type:
  
  Full‑time
• Job Function:
  Finance and Sales
• Industries:
  Pharmaceutical Manufacturing

• Office

• 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.

• Up to 5%

• BS in any scientific field
• Superior internal and external customer service/people skills
• Ability to manage multiple responsibilities and projects in a fast‑paced environment while performing efficiently
• Experience working with cross‑functional teams

• Minimum 4–5 years related experience in a pharmaceutical manufacturing environment
• Working knowledge of cGMPs, GLPs
• Strong knowledge of Trackwise to handle electronic Quality Management System (eQMS) data
• Strong working knowledge of MS Office software
• Preferably knowledge of EDMS, LMS, Master Control and Trackwise systems
• Strong familiarity with regulatory/compliance environment (cGMP, GLP) associated with parenteral drug manufacture

The presently‑anticipated base compensation pay range for this position is $82,000 to $100,000. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. 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.

If hired, the 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.

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.