Manufacturing Lead Investigator

Job Description

Position Title: Manufacturing Lead Investigator

Location: Lexington, MA

Duration: 6+ Months

Position Details:

Summary:

Under general supervision the Investigator will lead and manage evaluations of Environmental Excursions, Equipment Out of Tolerances (OOTs) / Out of specifications (OOS), and investigations to closure within the established timelines for the department. May also own and manage deviations with medium to moderate scope and complexity Will determine potential product impact, identify root cause and implementation of corrective and preventative actions in accordance with established procedures and timelines where required.

Responsibilities

          Describe the essential daily job functions and include % of time spent on each.

% of Time Job Function and Description

80% Completion of Quality systems:

• Create/monitor/author Out of Specification (OOS’) and Out of Tolerance (OOT’s) and environmental alert actions

• Monitor deviation progress and support process to closure

• Escalate conflicts that arise.

10% Work cross-functionally to assess and analyze deviations and investigations to determine impact and root cause

10% Identify, initiate and track corrective and preventative actions for investigations, OOS and OOT

Education and Experience Requirements          

• Bachelor’s in Science or a related discipline with 0-2 years of industry experience in a pharmaceutical/biotech or a high school diploma and 6+ years related industry experience in the manufacturing of biologics, pharmaceuticals or devices preferred

• Previous technical writing experience preferred

Key Skills, Abilities, and Competencies        

• Strong written and verbal communication skills

• Ability to exercise high-level of professional and business judgment when communicating with cross-functional teams and others at all levels of the organization

• Must be proficient with Microsoft Office applications, including Word, Excel and Power Point. Experience with more advanced document management applications a plus (including but not limited to TrackWise and SAP)

Complexity and Problem Solving      

• Ability to manage numerous priorities simultaneously

• Participate in problem resolution meetings/teams effectively

• Ability to shift priorities to meet required deadlines

• Effectively escalate and communicate issues to manager in a timely manner

• General knowledge of biopharmaceutical manufacturing 

• General understanding of industry regulations and cGMP compliance

• Ability to apply industry regulations to decision making process 

• Strong presentation skills desired. 

• Strong problem-solving skills and attention to detail

Internal and External Contacts     

• Facilitates, consults and collaborates with cross-functional teams including but not limited to Facilities and Engineering, Manufacturing Sciences & Operations Support, Quality, Validation, Health, Safety & Environment and Operational Excellence & Training.

Pre-Employment Questions:

 If you would like to pursue this position, please reply to this e-mail and provide us details in following areas. 

Also, please attach a copy of your updated resume, in word format, elaborating your projects in tune with the client’s requirement. 

This will assist us in placing you with one of our clients.

Ø What is your expected yearly salary or hourly rate?

Ø Please provide details about your education background – Qualification, Name of School, City & State

Ø Are you currently on any assignment? Is your current assignment contract or permanent?

Ø If given this opportunity, how soon would you be able to start on this project?

Ø Are you authorized to work for any employer in the US?

Ø Have you ever been convicted of a criminal offense?

If yes, please explain and provide details:

Note: Do not include convictions that have been annulled, erased, expunged, vacated, set aside, sealed by a court, or referred to a diversion program. Conviction of a crime will not necessarily disqualify you from employment. Factors such as age at the time of the offense, seriousness and nature of the violation, and rehabilitation will be considered when making employment decisions. A conviction record will not necessarily be a bar to employment.

Ø Do you have any disabilities that prevent you from successfully performing the essential functions of this job with or without accommodations?

Ø What is your home phone number?

Ø What is your cell phone number?

Ø On which e-mail ID do you wish to receive further communications in regards to this position?

Ø What is the best time for me to reach out to you for discussing this opportunity in detail?

Ø What is the best way to reach you in case an interview is scheduled?

Feel free to forward my email to your friends/colleagues who might be available

Qualifications

Additional Information

Thanks!!!

Warm Regards,

Amrit Singh

Clinical Recruiter

Integrated Resources, Inc

IT REHAB CLINICAL NURSING

Tel: (732) 429 1634  

Fax: (732) 549 5549

http://www.irionline.com

Inc. 5000 - 2007, 2008, 2009, 2010, 2011, 2012,2013 & 2014 (8th Year)

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