What are the responsibilities and job description for the Manager, Quality Control position at Curia?
Job Description
Manager, Quality Control in Hopkinton, MA
Build your future at Curia, where our work has the power to save lives.
Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.
We proudly offer
The Manager, Quality Control is responsible for the oversight of the Quality Control function at the site that includes both analytical and microbiology testing. The Manager will oversee a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting and overseeing testing, trending, continuous improvement, and reporting of results.
Responsibilities
This position does have supervisory responsibilities.
Qualifications
Knowledge, Skills And Abilities
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently is required to reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
Work environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee has the potential of being exposed to fumes or airborne particles and toxic or caustic chemicals (wearing proper Personal Protective Equipment will be required in these situations). The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; outside weather conditions; and risk of electrical shock (always being aware of one’s environment and taking proper precautions is required). The noise level in the work environment is usually moderate.
Employee will be responsible for generating hazardous waste for treatment, storage and disposal. Affected employee will need to be familiar with the applicable training requirements included in the Resources, Conservation and Recovery Act. Employee will understand waste labeling, secondary containment, chemical compatibility, storage time limits, container size and quantity limits, container integrity when waste is left unattended and improper disposal of hazardous materials.
We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.
All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.
Manager, Quality Control in Hopkinton, MA
Build your future at Curia, where our work has the power to save lives.
Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.
We proudly offer
- Generous benefit options (eligible first day of employment)
- Paid training, vacation and holidays (vacation accrual begins on first day of employment)
- Career advancement opportunities
- Education reimbursement
- 401K program with matching contributions
- Learning platform
- And more!
The Manager, Quality Control is responsible for the oversight of the Quality Control function at the site that includes both analytical and microbiology testing. The Manager will oversee a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting and overseeing testing, trending, continuous improvement, and reporting of results.
Responsibilities
- Manage and prioritize testing and operations of quality control team(s) involving samples as well as incoming, in-process and final products
- Ensure that the QC functions are completed in accordance with the Company and governmental standards of safety and quality, and that all experimental documentation is complete and timely
- Supervise a team of analysts and technicians including, but not limited to, the motivation, education, efficiency, performance management and productivity of these individuals
- Ensure that laboratory operations are conducted in a safe manner. Remain familiar with the contents of the Chemical Hygiene Plan. Follow safety rules fully
- The role requires trouble shooting technical issue in testing of QC samples, support QC analysts in testing challenges
- Define KPIs for QC lab performance and implement continuous improvement plans to improve RFT performance and efficiencies
- This role requires review of production schedule and proactively plan for QC lab testing
- Maintain compliance with regulations at all levels as well as strict adherence to standard operating procedures and cGMPs as necessary
- Organize workload and coordinate activities in order to carry out multiple projects concurrently and in accordance with established objectives, timelines and deadlines
- Support and manage all investigations of OOS, deviations and change control management and CAPAs within the QC function
- Oversee and perform pharmaceutical analysis to support operations
- Mentor and train team members on applicable techniques and equipment
This position does have supervisory responsibilities.
Qualifications
- BA/BS Degree in a relevant field and a minimum of 5 years of relevant related work experience, plus 2 years in a team leadership role of professional level individual contributors
- MA/MS Degree in a relevant field and a minimum of 3 year of relevant related work experience, plus 2 years in a team leadership role of professional level individual contributors.
Knowledge, Skills And Abilities
- Ability to recognize what needs to be done, take action, and accomplish results
- Strong oral and written communication skills, including effective listening
- Demonstrated ability to effectively utilize team resources
- Expert in cGMP, USP, EP and FDA regulations
- Technical competence including the understanding of theory and interpretation of all lab techniques
- Proficient use of computer software, including Microsoft Office Suite (excel, word) and other required software
- Strong organizational skills with the ability to multi-task
- Proficient in HPLC and GC method development and method validation with extensive experience with multiple other analytical techniques and analytical equipment
- Prior experience and knowledge in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently is required to reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
Work environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee has the potential of being exposed to fumes or airborne particles and toxic or caustic chemicals (wearing proper Personal Protective Equipment will be required in these situations). The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; outside weather conditions; and risk of electrical shock (always being aware of one’s environment and taking proper precautions is required). The noise level in the work environment is usually moderate.
Employee will be responsible for generating hazardous waste for treatment, storage and disposal. Affected employee will need to be familiar with the applicable training requirements included in the Resources, Conservation and Recovery Act. Employee will understand waste labeling, secondary containment, chemical compatibility, storage time limits, container size and quantity limits, container integrity when waste is left unattended and improper disposal of hazardous materials.
We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.
All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.
