What are the responsibilities and job description for the QC Chemist Senior position at Unither Pharmaceuticals?
Who we are?
We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients’ lives to as many people as possible.
With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 employees.
Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 300 employees.
Your role
Reporting to the QC Supervisor - Finished Products,
JOB SUMMARY:
This position performs routine analyses as required. Performs method development and validation, from design to execution, with some supervision. Manage projects with moderate input. May independently manage the activities of others. Implement technical improvements to laboratories quality systems. Provide technical resources for laboratory and mentor less experienced employees[BB1] as needed.
ESSENTIAL FUNCTIONS / RESPONSIBILITIES:
Completed Analyses
Performs, interprets, evaluates, and records routine and some non-routine analytical lab tests of materials, drug substances and drug products following CGMPscGMPs.
Execute protocols, experiments as written.
Reviews and approves laboratory data.
Maintains instruments and equipment. Sets up instruments and conducts sample tests. Performs routine calibration of instrumentation.
Ensures an adequate supply of test materials are available to perform daily testing.
Maintains and updates training records in a timely manner.
Methods & Validation
Technical Improvements to Laboratory Quality Systems
Safe, Compliant, Efficient Labs
Supports lab systems as assigned and maintains laboratory in compliance with SOPs, cGMPs, HS&E requirements, and FDA, DEA, USP, EP, and OSHA regulations.
Trainees Demonstrate the Ability to Execute Analytical Processes
Develops and implements training that ensures our ability to meet GMP, regulatory, and customer requirements and promotes first time right delivery.
Monitors the effectiveness of their training efforts and modifies approaches to ensure achievement of learning objectives.
Distinguishes between training and non-training needs and works with Supervisor/Manager to recommend an appropriate solution to performance problems.
Assists in effective implementation of new procedures by assisting Supervisor/Manager in design and delivery of training to employees.
Ensures documentation of training is retained as required by departmental procedures.
Performs method development and validation, from design to execution, with some supervision.
Seeks opportunities to improve existing methods.
Leads investigations, proposes solutions, and implements corrective action with minimal supervision.
conducts and writes laboratory investigations with minimal supervision.
Proactively identifies, communicates issues & proposes/implements solutions.
Recommends and assists in implementation of improvements to lab procedures and processes.
[BB1]Mentoring is something I want this level to working on. I am fine to not have it if we don't want to add it now
Your profile
EDUCATION & EXPERIENCE:
B.S. in Microbiology[BB1] Chemistry with minimum of three (3) years’ experience in an FDA regulated laboratory OR
B.S. in life sciences with five (5) years’ laboratory experience
Ability to read, communicate and legibly write in English, analyze and interpret scientific and regulatory documents.
Experienced in method development and validation.
Competency and demonstrated skill with chromatographic techniques (HPLC, GC, chiral separation) required and/or familiarity/competency with spectroscopic techniques (MS, UV/Vis, FTIR), physical characterization and/or dissolution.
Ability to evaluate data, perform trend analysis, identify potential issues, propose and implement solutions.
Computer Skills:
Basic Outlook skills as evidenced by creating and sending messages, working with address books, message handling, creating, and using personal folders, scheduling appointments, working with meeting requests and managing tasks.
Advanced Microsoft Word skills as evidenced by the ability to produce basic business letters and simple tables and charts; as well as check spelling, set tabs, change page orientation, sort, save, open and organize electronic files; create moderately complex documents containing tables and graphs, and ability to mail merge documents, apply page setup functions (margins, page numbers, footers, headers), create an index and/or table of contents, use search & replace, print labels and envelopes; as well as create and protect forms, use graphics, outline and organize long documents, create cross references, captions and bookmarks; use master documents to manage long documents, and create and use document templates.
Advanced Excel skills as evidenced by the ability to use workbooks, create simple formulas, insert and delete data, create and edit charts, filter and sort lists, and format data, link data, create and edit charts, change page orientation, add headers and footers, filter and sort lists, format data, insert rows, enter and sort data and produce graphs and charts; as well as the ability to enter and edit complex formulas, filter lists, sort ranges, create and run macros, and use data analysis tools (pivot tables, scenarios, etc.)
Intermediate PowerPoint skills as evidenced by the ability to create and save a presentation, add titles, edit and delete slides, reordering slides, applying slide masters, checking spelling, and adding clip art; as well as use and print notes, changing color schemes, changing fonts, bullets, slide backgrounds; adding a table, changing a slide layout, adding a chart, creating organizational charts, and search & replace.
SCOPE OF DECISION-MAKING: Decisions require complex analytical judgment. Plan and perform a wide variety of duties requiring general knowledge of company policies and procedures applicable within area of responsibilities and including their application to cases not routinely covered. Requires considerable judgment to work independently toward general results, devise methods, modify or adapt standard procedures to meet different conditions, make decisions based on precedent and company policies.
LEVEL OF SUPERVISION PROVIDED: Project direction of other employees performing the same or related work, including assigning, reviewing, checking work, eliminating ordinary supervisory/management positions.
INTERNAL / EXTERNAL CONTACTS: Regular inside and outside the organization: Requires regular contact with subordinates and/or other departments, with occasional contacts with individuals outside the organization. Also includes jobs with regular customer/client contacts.
PHYSICAL REQUIREMENTS/ENVIRONMENT:
Must demonstrate visual acuity, color recognition, finger dexterity.
The ability to read, write and communicate in English.
Work responsibilities involve chemical and biological agents that have assigned biological and chemical hazards.
Sitting approximately 50% of day and standing approximately 50% of day.
Work responsibilities may involve repetitive use of the hands through keyboarding, simple grasping, and fine manipulation.
Occasional lifting of up to thirty-five pounds.
Normal office environment and occasional controlled environment work that may require removal of jewelry and cosmetics.
Occasionally subjected to weekends, holidays, and irregular hours.
[BB1]Looks like this was accidently left in
Compensation Range
60,000.00 - 70,000.00 USD
At Unither, your base salary is just the beginning. Our Total Rewards include:
More Than Just a Paycheck At Unither, we don’t just offer competitive hourly wages—we also pay 100% of your medical premiums. That means no paycheck deductions for your healthcare, which can be worth an extra $1 to $3.50 an hour in your pocket compared to jobs where you pay part of the premium.
Learn more about us:
We are a dynamic company driven by a spirit of victory and are therefore pursuing strong growth while maintaining a close relationship with our customers and employees.
Our culture is based on 5 values: Respect, Responsibility, Trust, Courage and Innovation. We are committed to bringing these values to life with our employees by granting them a high degree of autonomy in the exercise of their profession and by encouraging their initiatives.
We are committed to providing them with working conditions and atmosphere that is conducive to their development and the expression of their potential.
We propose you to integrate a site that values the meaning of work and that entrusts our employees with a high level of responsibility.
Join us and make a difference!
We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients’ lives to as many people as possible.
With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 employees.
Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 300 employees.
Your role
Reporting to the QC Supervisor - Finished Products,
JOB SUMMARY:
This position performs routine analyses as required. Performs method development and validation, from design to execution, with some supervision. Manage projects with moderate input. May independently manage the activities of others. Implement technical improvements to laboratories quality systems. Provide technical resources for laboratory and mentor less experienced employees[BB1] as needed.
ESSENTIAL FUNCTIONS / RESPONSIBILITIES:
Completed Analyses
Performs, interprets, evaluates, and records routine and some non-routine analytical lab tests of materials, drug substances and drug products following CGMPscGMPs.
Execute protocols, experiments as written.
Reviews and approves laboratory data.
Maintains instruments and equipment. Sets up instruments and conducts sample tests. Performs routine calibration of instrumentation.
Ensures an adequate supply of test materials are available to perform daily testing.
Maintains and updates training records in a timely manner.
Methods & Validation
Technical Improvements to Laboratory Quality Systems
Safe, Compliant, Efficient Labs
Supports lab systems as assigned and maintains laboratory in compliance with SOPs, cGMPs, HS&E requirements, and FDA, DEA, USP, EP, and OSHA regulations.
Trainees Demonstrate the Ability to Execute Analytical Processes
Develops and implements training that ensures our ability to meet GMP, regulatory, and customer requirements and promotes first time right delivery.
Monitors the effectiveness of their training efforts and modifies approaches to ensure achievement of learning objectives.
Distinguishes between training and non-training needs and works with Supervisor/Manager to recommend an appropriate solution to performance problems.
Assists in effective implementation of new procedures by assisting Supervisor/Manager in design and delivery of training to employees.
Ensures documentation of training is retained as required by departmental procedures.
Performs method development and validation, from design to execution, with some supervision.
Seeks opportunities to improve existing methods.
Leads investigations, proposes solutions, and implements corrective action with minimal supervision.
conducts and writes laboratory investigations with minimal supervision.
Proactively identifies, communicates issues & proposes/implements solutions.
Recommends and assists in implementation of improvements to lab procedures and processes.
[BB1]Mentoring is something I want this level to working on. I am fine to not have it if we don't want to add it now
Your profile
EDUCATION & EXPERIENCE:
B.S. in Microbiology[BB1] Chemistry with minimum of three (3) years’ experience in an FDA regulated laboratory OR
B.S. in life sciences with five (5) years’ laboratory experience
Ability to read, communicate and legibly write in English, analyze and interpret scientific and regulatory documents.
Experienced in method development and validation.
Competency and demonstrated skill with chromatographic techniques (HPLC, GC, chiral separation) required and/or familiarity/competency with spectroscopic techniques (MS, UV/Vis, FTIR), physical characterization and/or dissolution.
Ability to evaluate data, perform trend analysis, identify potential issues, propose and implement solutions.
Computer Skills:
Basic Outlook skills as evidenced by creating and sending messages, working with address books, message handling, creating, and using personal folders, scheduling appointments, working with meeting requests and managing tasks.
Advanced Microsoft Word skills as evidenced by the ability to produce basic business letters and simple tables and charts; as well as check spelling, set tabs, change page orientation, sort, save, open and organize electronic files; create moderately complex documents containing tables and graphs, and ability to mail merge documents, apply page setup functions (margins, page numbers, footers, headers), create an index and/or table of contents, use search & replace, print labels and envelopes; as well as create and protect forms, use graphics, outline and organize long documents, create cross references, captions and bookmarks; use master documents to manage long documents, and create and use document templates.
Advanced Excel skills as evidenced by the ability to use workbooks, create simple formulas, insert and delete data, create and edit charts, filter and sort lists, and format data, link data, create and edit charts, change page orientation, add headers and footers, filter and sort lists, format data, insert rows, enter and sort data and produce graphs and charts; as well as the ability to enter and edit complex formulas, filter lists, sort ranges, create and run macros, and use data analysis tools (pivot tables, scenarios, etc.)
Intermediate PowerPoint skills as evidenced by the ability to create and save a presentation, add titles, edit and delete slides, reordering slides, applying slide masters, checking spelling, and adding clip art; as well as use and print notes, changing color schemes, changing fonts, bullets, slide backgrounds; adding a table, changing a slide layout, adding a chart, creating organizational charts, and search & replace.
SCOPE OF DECISION-MAKING: Decisions require complex analytical judgment. Plan and perform a wide variety of duties requiring general knowledge of company policies and procedures applicable within area of responsibilities and including their application to cases not routinely covered. Requires considerable judgment to work independently toward general results, devise methods, modify or adapt standard procedures to meet different conditions, make decisions based on precedent and company policies.
LEVEL OF SUPERVISION PROVIDED: Project direction of other employees performing the same or related work, including assigning, reviewing, checking work, eliminating ordinary supervisory/management positions.
INTERNAL / EXTERNAL CONTACTS: Regular inside and outside the organization: Requires regular contact with subordinates and/or other departments, with occasional contacts with individuals outside the organization. Also includes jobs with regular customer/client contacts.
PHYSICAL REQUIREMENTS/ENVIRONMENT:
Must demonstrate visual acuity, color recognition, finger dexterity.
The ability to read, write and communicate in English.
Work responsibilities involve chemical and biological agents that have assigned biological and chemical hazards.
Sitting approximately 50% of day and standing approximately 50% of day.
Work responsibilities may involve repetitive use of the hands through keyboarding, simple grasping, and fine manipulation.
Occasional lifting of up to thirty-five pounds.
Normal office environment and occasional controlled environment work that may require removal of jewelry and cosmetics.
Occasionally subjected to weekends, holidays, and irregular hours.
[BB1]Looks like this was accidently left in
Compensation Range
60,000.00 - 70,000.00 USD
- The referenced compensation range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.
At Unither, your base salary is just the beginning. Our Total Rewards include:
- 100% employer-paid medical premiums (a $2,000–$6,000 annual value)
- 401(k) contributions: 6% match plus an additional 4% company-funded contribution
- HSA contributions with wellness incentives
- And more—because we invest in your health, your future, and your peace of mind.
More Than Just a Paycheck At Unither, we don’t just offer competitive hourly wages—we also pay 100% of your medical premiums. That means no paycheck deductions for your healthcare, which can be worth an extra $1 to $3.50 an hour in your pocket compared to jobs where you pay part of the premium.
Learn more about us:
We are a dynamic company driven by a spirit of victory and are therefore pursuing strong growth while maintaining a close relationship with our customers and employees.
Our culture is based on 5 values: Respect, Responsibility, Trust, Courage and Innovation. We are committed to bringing these values to life with our employees by granting them a high degree of autonomy in the exercise of their profession and by encouraging their initiatives.
We are committed to providing them with working conditions and atmosphere that is conducive to their development and the expression of their potential.
We propose you to integrate a site that values the meaning of work and that entrusts our employees with a high level of responsibility.
Join us and make a difference!
Salary : $2,000 - $6,000