Associate Manager, Quality Assurance (Visual Inspection)

BioSpace; Town of East Greenbush (NY); On-site; USD 90,000 - 174,000; Full time

Job summary

An established industry player is seeking an Associate Manager for Quality Assurance, specializing in visual inspection. This pivotal role involves leading a QA team, ensuring compliance within a cleanroom environment, and making critical on-the-floor decisions. The ideal candidate will have a strong background in cGMP manufacturing and visual inspection, along with exceptional interpersonal and problem-solving skills. Join this dynamic team and contribute to maintaining high-quality standards in a fast-paced environment that values innovation and teamwork.

Benefits

Health and Wellness Programs

Fitness Centers

Equity Awards

Annual Bonuses

Paid Time Off

Qualifications

• 6+ years in pharmaceutical or biologics manufacturing.
• Experience in visual inspection of liquid and lyophilized products.

Responsibilities

• Supervise QA team and manage quality assurance processes.
• Conduct compliance monitoring and coordinate QA resources.

Skills

Visual Inspection

cGMP Manufacturing

Interpersonal Skills

Problem-Solving Skills

Team Leadership

Education

BA/BS in Life Sciences

Job description

Associate Manager, Quality Assurance (Visual Inspection)

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Associate Manager, Quality Assurance (Visual Inspection)

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We are currently looking to fill an Associate Manager QA (Visual Inspection) position. This position will be responsible for supervising a team of QA employees and their prospective area(s) and/or assignments. This position is expected to have a daily on the floor presence in a clean room environment meaning standing for up to 8 hours with no breaks is feasible.

In this role, a typical day might include the following:

• Responsible for all aspects of QA Team including review and approval of the following types of documents, relating to area functions: Master Records, Executed Records, Failure Investigations, Change Controls, CAPAs, SOPs, Validation Protocols and Summary Reports, and Incursions.
• Approves various documents relating to area function, including those listed above.
• Coordinates QA resource assigned to functional area to meet goals and timings; coordinates prioritization of activities with area management.
• Performs compliance monitoring of area operations, including trending of failures and evaluating efficiency of corrective actions.
• Reviews customer requirements and implements required processes, as needed, to meet customer expectations regarding Quality.
• Provide on-the-floor decision making
• Interviews, hires, orients, and trains incoming personnel.
• Leads personnel by developing work plans, establishing objectives, and assigning tasks.
• Counsels employees about work performance; conducts hiring and discharge interviews.
• Participates in regulatory and customer audits.
  
  
  

This Role May Be For You If You

• Are able to pass a visual acuity exam according to SOP requirements
• Have knowledge of cGMP manufacturing environment and familiarity with visual inspection of liquid and lyophilized products
• Are experienced using and / or developing qualification kits and qualifying operators
• Possess strong interpersonal, cross- cultural, communication and problem-solving skills
• Exhibit confidence, has a high emotional IQ, and demonstrated ingenuity, creativity and resourcefulness
• Understand and listen to team members' and partners' needs while supporting a positive team environment
  
  
  

Gowning and Environment

• Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
• Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire
  
  
  

Preferred

To be considered for this role you must hold a BA / BS degree in a life sciences discipline or related field (chemistry, biology, or pharmacy preferred) and the following minimum amounts of experience in pharmaceutical or biologics manufacturing environment for each level:

• Associate Manager 6+ years
• Manager 7+ years
  
  
  

Some supervisory and/or leadership experience preferred. May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

#REGNQA

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$90,800.00 - $173,400.00

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Internet News

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