MCS Senior Associate Quality Assurance

Job Description

Job Description

Payrate: $32.00 - $33.00/hr.

Summary:
This position supports company’s Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Substance manufacturing areas. Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering areas/staff in the execution of their processes, procedures, and use of quality systems. Duties include purposeful presence on the floor, electronic batch record review, SOP revision & approval, work order approval, and quality approval of minor deviations . Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate will also represent functional area for the Drug Substance Quality Assurance department in the execution of projects necessary to achieve departmental operational goals and will work in a team matrix environment.

Qualifications:

• The ideal candidate will have 1–2+ years of hands-on experience in a regulated GMP environment, preferably within the pharmaceutical, biotech, or food industries.
• While a bachelor’s degree in a relevant scientific field (e.g., biology, chemistry, biochemistry) is preferred, direct industry experience is more important.
• Candidates should be familiar with manufacturing or quality operations and understand the pace and expectations of a high-volume, highly cross-functional environment.
• This role requires individuals who are proactive, able to work independently with minimal oversight, and comfortable escalating issues appropriately.
• Candidates seeking long-term opportunities with potential for FTE conversion will be prioritized; this is not intended for short-term or transitional job seekers.
• Fresh graduates without industry experience will not be considered.
  
  

Preferred Qualifications:

• Bachelor's Degree in Biochemistry, Biology, Chemistry, or related science field.
• Demonstrated ability to perform GMP operations including following detailed SOPS, maintaining training, and good documentation practices.
• Also, ability to make Quality based decisions in order to ensure compliance.
• Experience managing projects through to completion & meeting timelines.
• Evaluating documentation and operations according to company procedures.
• Experience working with Quality Systems, Strong organizational skills and ability to manage multiple tasks at one time/ Effective communication skills (both written and verbal)
• Demonstrated ability to work as both a team player and independently
• Display leadership attributes and drive improvement initiatives.

Top Must Have Skill Sets:

• Purification knowledge
• Cell Culture Knowledge
• Self driven/starter
• Strong communication skills
• Strong team work ethic

Pay Transparency:  The typical base pay for this role across the U.S. is: $32.00 - $33.00 /hr . Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law. 

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