With a minimum amount of direct supervision, carries out all aspects of GMP regulations and quality assurance.

• Under supervision, responsible for writing and revising Standard Operating Procedures, and maintaining Change Control Systems.

· Tracks and investigates deviations in production processes, facility failures and out of specification testing.
· Interacts with contract laboratories and analyzes quality control data.
· Prepares and reviews documentation associated with filing Drug Master Files, including batch record generation and control.
· Prepares certificates of analysis for released products
· Controls documentation on facilities, equipment, packaging and labeling.
· Participates in FDA inspections.
· Responsible for maintaining a neat, clean and safe work area.
· Performs other duties of similar complexity as directed.
· Ensures that all necessary QMS processes are adequately defined, effectively deployed, and continually kept up (this may include document control responsibilities).
· Responsible to report on the effectiveness and needed improvements of the QMS to top management for review and action.
· Coordinates audits with external parties, such as customers or the ISO registrar, and other quality related communications that may be needed.

Key Responsibilities
· Ability to define problems, collect data, establish facts, and draw conclusions
· Strong organizational, problem-solving, and analytical skills
· Strategic thinker who can see long-term goals and balance against short and intermediate-term needs
Ability to manage priorities and workflow

• Ability to work independently and as a member of various teams and committees

· Proven ability to handle multiple projects and meet deadlines

Skills, Knowledge and Expertise
Specific Skills Required:
·Strong understanding of chemistry
·Prior experience in similar environment
Educational Requirements:
·High school diploma or equivalent required
Requires a Bachelor’s degree in chemistry with 4-7 years experience working in a GMP/regulatory environment

Benefits
This position is eligible for a bonus based on individual and company performance.

Comprehensive Benefits:

• Medical, Dental, Vision - effective day one of employment.
• 401(k) with company match with immediate vesting - effective first of the month, following date of hire.
• First 3% is matched dollar-for-dollar.
• Second 3% is matched at 70 cents on the dollar.

• 3 Weeks' Vacation
• 12 Paid Holidays
• Basic Life, AD&D, STD, and LTD provided at no cost to employee.
• Ancillary benefits available such as voluntary life, accident, critical illness, hospital indemnity, identity theft, whole life with long-term care.

About Ascensus Specialties
We partner with companies of all kinds to develop chemical solutions that improve everyday products and processes to enhance people’s lives.

Department
Quality
Employment Type
Full Time
Location
Newburyport, MA
Workplace type
Onsite

Job Type: Full-time

Pay: $90,000.00 - $100,000.00 per year

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