Quality Control Laboratory Manager
Top Benefits
About the role
Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products.
From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide.
At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain.
Why join Bora?
- Competitive salary
- A modern and state-of-the-art facility
- An on-site cafeteria with dedicated chefs
- On-site gym and basketball court
Click here for a video tour of our Mississauga facility: https://lnkd.in/evhPktDN
Position Description
Job Title: Manager, QC Laboratory
Department: Quality Control
Position Reporting To : Director, Quality
No. Of Direct Reports: 4-6
No. Of Indirect Reports: 40-60
Employment Type: Fulltime Permanent
General Description
The Quality Control Laboratory Manager oversees the entirety of the quality control functions. All systems related to the analyses of raw materials, packaging components, finished goods, microbiology, retain management, stability management and environmental monitoring. The QC Manager ensures laboratory compliance is maintained (as the QC manager is the face of Quality control in regulatory and customer audits) and staff are accountable for on time and in full delivery of site priorities. Key responsibilities are listed but not limited to the following.
Responsibilities
- Manage all Quality Control Laboratories with respect to; testing of marketed products, establishing acceptability of product disposition based on conformance to agreed specifications and site environmental monitoring programs.
- Ensure the laboratories are properly resourced and outfitted to perform their necessary functions.
- Represent the department in regulatory (i.e., Health Canada, FDA etc.) and customer audits and meetings regarding laboratory and analytical issues.
- Provide responses to deficiency letters and audit observations as they relate to the quality laboratories.
- Through the introduction of training and career development, develop the Quality Control staff to ensure accurate and reliable data are generated to comply with QMS and GMP requirements.
- Conduct employee assessment including hiring, development, terminations, and promotions.
- Oversee the purchase, validation and implementation of new laboratory equipment including the ongoing calibration and preventative maintenance programs.
- Provide guidance and expertise on the resolution of technical problems and directing the investigation teams to resolve analytical, quality or production problems at Mississauga or at contract manufacturing/laboratory locations.
- Prepare technical reports, standard operating procedures, product specifications and analytical methods.
- Manage analytical method transfers to the QC laboratories ensuring accurate analytical procedures are established for routine use in the QC Laboratories.
- Implement the laboratory standards to expand capabilities, increase laboratory efficiency, improve data quality and reduce costs.
Qualifications
Experience and Skills
- 5-10 years of relevant supervisory experience.Extensive knowledge of analytical testing (both chemistry and microbiology) via in-house and compendial methods for multiple finished dosage forms and raw materials.
- Expertise required in science (chemistry preferred) or operational function in order to understand, investigate and make quality decisions on changes to existing or new processes.
- Thorough operational knowledge of the “letter and spirit’ of regulatory laws and directives, and liability for non-compliance.
- Awareness of trends in the interpretation of the GMPs and industry-wide QC problems and their impact on Bora and its customers.
- Possess understanding of group dynamics and can effectively influence group decision-making. (Must be a decision maker).
- Strong technical background in chemical theory, analytical methodology, laboratory instrumentation and computer applications related to pharmaceutical analysis.
- Must have excellent communication skills (oral and written).
- Must foster an environment based on collaboration and Teamwork.
- Must be customer focused.
Education
Required:
- Bachelor's degree in science or related field with equivalent on the job experience through years of service.
Preferred:
- Related Scientific Discipline – Chemistry preferred.
Working Conditions
- Manager role, permanently located on site. Working within the office and quality control laboratories.
- Part of the Quality Leadership Team.
- 37.5+ hour work week.
Bora is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals to apply to our career opportunities. Bora is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at accessibility@bora-corp.com.
Please do not send resumes to this email and instead apply through the online application process of this posting.
About Bora Pharmaceuticals
Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in complex oral solid dose, liquids, semi-solids, ophthalmics and nasal sprays for pharmaceutical products. We operate from early phase clinical right through to commercial manufacturing with full packaging capabilities. From cell-line development and formulation to analytical services, clinical cGMP manufacturing and sterile fill/finish services, Bora now provides tailored development and manufacturing services to biologics developers. Bora owns and operates in ten state-of-the-art CGMP manufacturing facilities across Asia and North America – delivering to more than 100 markets around the world. Our sites have the highest international standards for manufacturing, packaging, R&D and analytical testing.
As a future focused CDMO, we know better than most that our own success is shaped by our partners victories. That's why, when you choose Bora - we make success more certain by following Bora’s 5Ps – Promises, Partnerships, Pride, People, and Progress. These 5 principles are Bora’s Pledge to our customers.
Follow us to find out more and keep up to date with Bora Pharmaceuticals.
Quality Control Laboratory Manager
Top Benefits
About the role
Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products.
From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide.
At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain.
Why join Bora?
- Competitive salary
- A modern and state-of-the-art facility
- An on-site cafeteria with dedicated chefs
- On-site gym and basketball court
Click here for a video tour of our Mississauga facility: https://lnkd.in/evhPktDN
Position Description
Job Title: Manager, QC Laboratory
Department: Quality Control
Position Reporting To : Director, Quality
No. Of Direct Reports: 4-6
No. Of Indirect Reports: 40-60
Employment Type: Fulltime Permanent
General Description
The Quality Control Laboratory Manager oversees the entirety of the quality control functions. All systems related to the analyses of raw materials, packaging components, finished goods, microbiology, retain management, stability management and environmental monitoring. The QC Manager ensures laboratory compliance is maintained (as the QC manager is the face of Quality control in regulatory and customer audits) and staff are accountable for on time and in full delivery of site priorities. Key responsibilities are listed but not limited to the following.
Responsibilities
- Manage all Quality Control Laboratories with respect to; testing of marketed products, establishing acceptability of product disposition based on conformance to agreed specifications and site environmental monitoring programs.
- Ensure the laboratories are properly resourced and outfitted to perform their necessary functions.
- Represent the department in regulatory (i.e., Health Canada, FDA etc.) and customer audits and meetings regarding laboratory and analytical issues.
- Provide responses to deficiency letters and audit observations as they relate to the quality laboratories.
- Through the introduction of training and career development, develop the Quality Control staff to ensure accurate and reliable data are generated to comply with QMS and GMP requirements.
- Conduct employee assessment including hiring, development, terminations, and promotions.
- Oversee the purchase, validation and implementation of new laboratory equipment including the ongoing calibration and preventative maintenance programs.
- Provide guidance and expertise on the resolution of technical problems and directing the investigation teams to resolve analytical, quality or production problems at Mississauga or at contract manufacturing/laboratory locations.
- Prepare technical reports, standard operating procedures, product specifications and analytical methods.
- Manage analytical method transfers to the QC laboratories ensuring accurate analytical procedures are established for routine use in the QC Laboratories.
- Implement the laboratory standards to expand capabilities, increase laboratory efficiency, improve data quality and reduce costs.
Qualifications
Experience and Skills
- 5-10 years of relevant supervisory experience.Extensive knowledge of analytical testing (both chemistry and microbiology) via in-house and compendial methods for multiple finished dosage forms and raw materials.
- Expertise required in science (chemistry preferred) or operational function in order to understand, investigate and make quality decisions on changes to existing or new processes.
- Thorough operational knowledge of the “letter and spirit’ of regulatory laws and directives, and liability for non-compliance.
- Awareness of trends in the interpretation of the GMPs and industry-wide QC problems and their impact on Bora and its customers.
- Possess understanding of group dynamics and can effectively influence group decision-making. (Must be a decision maker).
- Strong technical background in chemical theory, analytical methodology, laboratory instrumentation and computer applications related to pharmaceutical analysis.
- Must have excellent communication skills (oral and written).
- Must foster an environment based on collaboration and Teamwork.
- Must be customer focused.
Education
Required:
- Bachelor's degree in science or related field with equivalent on the job experience through years of service.
Preferred:
- Related Scientific Discipline – Chemistry preferred.
Working Conditions
- Manager role, permanently located on site. Working within the office and quality control laboratories.
- Part of the Quality Leadership Team.
- 37.5+ hour work week.
Bora is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals to apply to our career opportunities. Bora is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at accessibility@bora-corp.com.
Please do not send resumes to this email and instead apply through the online application process of this posting.
About Bora Pharmaceuticals
Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in complex oral solid dose, liquids, semi-solids, ophthalmics and nasal sprays for pharmaceutical products. We operate from early phase clinical right through to commercial manufacturing with full packaging capabilities. From cell-line development and formulation to analytical services, clinical cGMP manufacturing and sterile fill/finish services, Bora now provides tailored development and manufacturing services to biologics developers. Bora owns and operates in ten state-of-the-art CGMP manufacturing facilities across Asia and North America – delivering to more than 100 markets around the world. Our sites have the highest international standards for manufacturing, packaging, R&D and analytical testing.
As a future focused CDMO, we know better than most that our own success is shaped by our partners victories. That's why, when you choose Bora - we make success more certain by following Bora’s 5Ps – Promises, Partnerships, Pride, People, and Progress. These 5 principles are Bora’s Pledge to our customers.
Follow us to find out more and keep up to date with Bora Pharmaceuticals.