SENIOR QUALITY SPECIALIST Cambridge, East of England, England
Job description
DPS Engineering is looking for a Senior Quality Specialist for a Small Molecule GMP Facility in Cambridge, MA. The Sr. QA specialist/consultant will support the GMP facility as well as disposition activities.
Key Responsibilities
- Oversee and review executed electronic and paper batch record documentation.
- Author and review SOPs, policies and batch production/testing records to ensure compliance and adherence to regulations/cGMP operations.
- Closely partner with peers for rapid review of batch-related documentation.
- Enforce adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.
- Monitor process operations to ensure compliance with specifications.
- Assist in the investigation of procedural deviations.
- Oversees execution of CAPAs, deviations and change controls in support of PCV manufacturing.
- Reviews minor manufacturing deviations.
- Develop batch records, SOPs and training materials as needed.
- Demonstrate a general knowledge of standard manufacturing compliance, quality disposition, quality system review.
- Utilize knowledge to improve operational efficiency.
- Participate in quality oversight of manufacturing through real-time observations of activities.
Skills & Qualifications
- At least 5 years of QA or Manufacturing experience in a GMP manufacturing environment with a Bachelor’s Degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical Engineering, Biochemistry or related field.
- Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company preferably in GMP or GLP
- Ability to collaborate fluidly with peers, supervisors and cross-functional support groups required
- Exceptional written, oral communication, and organizational skills required
- Must be able to work under general direction to plan, coordinate, and ensure completion of engineering team deliverables.
- Effective verbal and written communication skills.
- Excellent interpersonal, teamwork, and leadership skills required.
- Participates in determining objectives of assignment and plans, schedules and arranges own activities in accomplishing milestone achievements.
The Company
DPS Group is a global EPCM firm offering full-service solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) industries. DPS is dedicated to delivering successful projects with a ‘client-first’ mentality and personal touch across a range of market sectors: Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start-up.
DPS Engineering Inc. is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. DPS does not discriminate in employment opportunities or practices on the basis of: race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status or any other characteristic protected by country, regional or local law.
#LI-NH1
Summary
DPS Engineering is looking for a Senior Quality Specialist for a Small Molecule GMP Facility in Cambridge, MA. The Sr. QA specialist/consultant will support the GMP facility as well as disposition activities.
Key Responsibilities
- Oversee and review executed electronic and paper batch record documentation.
- Author and review SOPs, policies and batch production/testing records to ensure compliance and adherence to regulations/cGMP operations.
- Closely partner with peers for rapid review of batch-related documentation.
- Enforce adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.
- Monitor process operations to ensure compliance with specifications.
- Assist in the investigation of procedural deviations.
- Oversees execution of CAPAs, deviations and change controls in support of PCV manufacturing.
- Reviews minor manufacturing deviations.
- Develop batch records, SOPs and training materials as needed.
- Demonstrate a general knowledge of standard manufacturing compliance, quality disposition, quality system review.
- Utilize knowledge to improve operational efficiency.
- Participate in quality oversight of manufacturing through real-time observations of activities.
Skills & Qualifications
- At least 5 years of QA or Manufacturing experience in a GMP manufacturing environment with a Bachelor’s Degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical Engineering, Biochemistry or related field.
- Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company preferably in GMP or GLP
- Ability to collaborate fluidly with peers, supervisors and cross-functional support groups required
- Exceptional written, oral communication, and organizational skills required
- Must be able to work under general direction to plan, coordinate, and ensure completion of engineering team deliverables.
- Effective verbal and written communication skills.
- Excellent interpersonal, teamwork, and leadership skills required.
- Participates in determining objectives of assignment and plans, schedules and arranges own activities in accomplishing milestone achievements.
The Company
DPS Group is a global EPCM firm offering full-service solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) industries. DPS is dedicated to delivering successful projects with a ‘client-first’ mentality and personal touch across a range of market sectors: Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start-up.
DPS Engineering Inc. is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. DPS does not discriminate in employment opportunities or practices on the basis of: race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status or any other characteristic protected by country, regional or local law.
#LI-NH1
